MAUDE Adverse Event Report: SYNTHES BETTLACH IMPACTOR F/PFNA BLADE; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 03.010.410

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: date of event is unknown.Device is an instrument and is not implanted/explanted.(b)(6).Device is not distributed in the united states.Subject device has been received and is currently in the evaluation process.Part number: 03.010.410, synthes lot number: 9419710: release to warehouse date: may 18, 2015.Mfg.Site: (b)(4).No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.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) is as follows; it was reported that the blue plastic handle is loose from shaft of an impactor for proximal femoral nail antirotation (pfna) blade.The welding seam broke at the proximal end.It is unknown when the issue occurred, but there was no patient involvement.This is report number 1 of 1 for (b)(4).

Manufacturer Narrative

Additional narrative: a manufacturing investigation action was performed.The report indicates that: the manufacturing documents were reviewed and no complaint related issues were found.The present failure mode is already addressed, which did result in field action, product removal.Therefore no further evaluation on this complaint is needed.The preliminary cause was identified as a design issue of the welding of the impactor (weld is not resistant to support hammering operations).Device 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: IMPACTOR F/PFNA BLADE
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6159316
• MDR Text Key: 62350937
• Report Number: 9612488-2016-10502
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.010.410
• Device Lot Number: 9419710
• Other Device ID Number: (01)07611819349476(10)9419710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/18/2015
• 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