FDA Adverse Event Malfunction Summary report: N

BATTERY RECIPROCATOR

MDR report key: 3001352 · Received March 13, 2013

Report

Report Number: 8030965-2013-00859
Event Type: Malfunction
Date Received: March 13, 2013
Date of Event: February 11, 2013
Report Date: February 12, 2013
Manufacturer: SYNTHES GMBH
Product Code: MOQ
PMA / PMN Number: EXEMPT
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SC
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PLACEHOLDER.

Additional Manufacturer Narrative · 1

DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED.

Additional Manufacturer Narrative · 1

DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND THE REPORTED PROBLEM WAS CONFIRMED. THIS CONDITION WAS LIKELY DUE TO NORMAL WEAR OUT FROM USE OVER TIME.

Additional Manufacturer Narrative · 1

DEVICE WAS USED FOR TREATMENT NOT DIAGNOSIS. THESE FIELDS WERE SUBMITTED IN ERROR. AFTER FURTHER REVIEW, THIS FILE HAS BEEN DEEMED NON-REPORTABLE BY POST MARKET RISK MANAGEMENT. PLACEHOLDER.

Description of Event or Problem · 1

THIS REPORT IS #1 OF 1 FOR COMPLAINT (B)(4).

Description of Event or Problem · 1

THE USER FACILITY REPORTS THE BATTERY RECIPROCATOR WOULD NOT RUN. IT IS REPORTED MULTIPLE BATTERIES WERE TESTED WITH THE SAME RESULTS. IT IS ALSO REPORTED EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, NO PATIENT INVOLVEMENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
105734	BATTERY RECIPROCATOR		MOQ	SYNTHES GMBH		2560

Patients

Seq	Age	Sex	Outcome	Treatment
1				BATTERY RECIPROCATOR