STANDARD INSERTION HANDLE

Report

Report Number: 1719045-2015-10060
Event Type: Malfunction
Date Received: January 26, 2015
Date of Event: January 12, 2015
Report Date: January 13, 2015
Manufacturer: SYNTHES MONUMENT
Product Code: LXH
PMA / PMN Number: PEXEMPT
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

AN INVESTIGATION SUMMARY WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT: THE INSTRUMENTS WERE ANALYZED FOR CONFORMANCE TO PRINT SPECIFICATIONS AS WELL AS THE DEVICE HISTORY RECORD WAS RESEARCHED; NO ABNORMAL FINDINGS WERE IDENTIFIED. MANUFACTURING AND INSPECTION RECORDS INDICATED NO PROBLEMS WITH THE LOT IN QUESTION. IT IS CLEARLY VISIBLE THAT THE INSTRUMENTS ARE IN A DESOLATE CONDITION. THE GUIDES ARE WORN OUT OF INSERTION HANDLE. THE CONNECTION IN MOUNTED CONDITION HAD CLEARANCE BETWEEN AIMING ARM AND INSERTION HANDLE. PLEASE NOTE THAT THESE INSTRUMENTS WERE MANUFACTURED IN YEAR 2004 AND SHOWS HEAVY USE DURING THIS PERIOD OF TIME. WE HAVE TO ASSUME THAT MULTIPLE MECHANICAL FORCE WELL BEYOND ITS CALCULATED DESIGN HAS BEEN APPLIED DURING USING OVER THESE YEARS, WHICH RESULTED THIS OCCURRENCES. VISUAL INSPECTION HAS SHOWN THAT THE INSTRUMENTS ARE IN DESOLATE CONDITIONS. AS NO PRODUCT FAULT COULD BE DETECTED, NO FURTHER ACTION REQUIRED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Additional Manufacturer Narrative · 1

(B)(4).DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Additional Manufacturer Narrative · 1

DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. A DEVICE HISTORY REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT EF PRECISION MANUFACTURED THE STANDARD INSERTION HANDLE, P/N 03.010.045, AND LOT #4777461 ON PO #422936 FOR 93 PIECES DELIVERED JUNE 1, 2004 AND PROCESSED ON BRANDYWINE WORK ORDER #(B)(4). INITIALLY, THE PART CONFORMED TO THE SUPPLIER¿S CERTIFICATE OF CONFORMANCE, DATED MAY 25, 2004; THE LOT WAS INSPECTED AND 66/93 CONFORMED TO SYNTHES INSPECTION SHEET MCN0005. THE 66 CONFORMING PIECES WERE SPLIT TO LOT #4803780 AND PROCESSED ON WORK ORDER #812689 (1 PIECE WAS SCRAPPED AT PACKAGING FOR UNKNOWN CAUSE). THIS LOT WAS RELEASED TO THE WAREHOUSE ON JUNE 24, 2004. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Additional Manufacturer Narrative · 1

ADDITIONAL NARRATIVE: CORRECTED DATA, COMPLAINT NUMBER REPORTED AS (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Description of Event or Problem · 1

DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THIS AIMING DEVICE IS NOT PUNCTUAL THE HOLES LEAD INTO WRONG DIRECTION. IT WAS REPORTED THAT IT WAS USED AS IT IS WRITTEN IN THE FLYER, SO THEY WERE USING PROTECTION SLEEVE, YES THEY OPERATED A NAIL IN, DIFFERENT SIZES WERE TRIED TO MATCH, AND IT WAS NOT PUNCTUAL AT ANY TIME. A 9MM 315 MM NAIL WAS USED. IT WAS STATED THAT A 10-15 MINUTES DELAY OCCURRED IN SURGERY. THIS IS REPORT 1 OF 5 FOR (B)(4).

Description of Event or Problem · 1

THIS REPORT IS 1 OF 5 FOR (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
59988	STANDARD INSERTION HANDLE	MISC ORTHO SURGICAL INSTR	LXH	SYNTHES MONUMENT		4777461

Patients

Seq	Age	Sex	Outcome	Treatment
1	35 YR