FDA Adverse Event Injury Summary report: N

CORTSCR 4.5 SELF-TAP L24 TI

MDR report key: 2771993 · Received September 28, 2012

Report

Report Number: 8030965-2012-00927
Event Type: Injury
Date Received: September 28, 2012
Date of Event: August 5, 2012
Report Date: August 30, 2012
Manufacturer: SYNTHES GMBH
Product Code: KTT
PMA / PMN Number: K974537
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: SZ
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. REVIEW OF MFG RECORDS HAS BEEN REQUESTED.

Additional Manufacturer Narrative · 1

INVESTIGATION COORDINATED BY SYNTHES (B)(4). REPORT RECEIVED INDICATES THE EXAMINATION OF THE RAW-MATERIAL TESTING CERTIFICATES AND THE MANUFACTURING PAPERS FOR THE ARTICLE SHOWED NO DEVIATIONS REGARDING MATERIAL ANALYSIS, STRENGTH AND STRUCTURAL STABILITY. THE VALUES WERE IN COMPLIANCE WITH AO/ASIF SPECIFICATION AND WITH THE INTERNATIONAL STANDARD. THIS DEVICE WAS MANUFACTURED IN (B)(6) 2011 ACCORDING TO THE SPECIFICATIONS. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

Description of Event or Problem · 1

DURING THE INSERTION OF THE SCREWS, TWO SCREW HEADS BROKE OFF. THE BROKEN FRAGMENTS WERE LEFT IN THE PT AND THE BROKEN HEADS WERE DISCARDED. THE PT IS WELL. THIS REPORT IS #2 OF 2 FOR THE SAME EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	CORTSCR 4.5 SELF-TAP L24 TI	CORTSCR 4.5 SELF-TAP L24 TI	KTT	SYNTHES GMBH		7503835

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention	SCREW