MAUDE Adverse Event Report: SYNTHES TUTTLINGEN IN-SITU BENDING & TWISTING HANDLE/120°; INSTR, BENDING OR CONTOURING

Catalog Number 03.100.093

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 03/28/2014

Event Type  malfunction  

Manufacturer Narrative

A manufacturing evaluation was completed: the instrument was analyzed for conformance to print specifications as well as the device history record was researched, no abnormal findings were identified.The view of the broken surfaces does not show any anomalies of materials structure, what indicates material conformity as well.The investigation of the complained instrument shows that a part of the tip is broken at the welding.Unfortunately we are not able to determine the exact cause which has led to this occurrence.It is likely that too much mechanical force had been applied during the surgery.No product fault could be detected.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.

Event Description

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that part of the instrument was broken while bending a 3.5 reconstruction plate.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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.

• Brand Name: IN-SITU BENDING & TWISTING HANDLE/120°
• Type of Device: INSTR, BENDING OR CONTOURING
• Manufacturer (Section D): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 7853 2; GM 78532
• Manufacturer (Section G): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 7853 2; GM 78532
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 3800728
• MDR Text Key: 12022509
• Report Number: 9680938-2014-10016
• Device Sequence Number: 1
• Product Code: HXP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.100.093
• Device Lot Number: T968408
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/28/2014
• Initial Date FDA Received: 05/08/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1