MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH IMPACTOR F/PFNA BLADE

Catalog Number 03.010.410

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 11/06/2017

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: (b)(6).Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(510k): device is not distributed in the united states, but is similar to device marketed in the usa.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 (b)(6) reports an event in sweden as follows: it was reported that the blue plastic on the handle detached from the metal during the insertion of the proximal femoral nail antirotation (pfna) blade on (b)(6) 2017.There is no reported adverse consequence for the patient.Procedure was completed successfully with no other medical intervention required and no surgical delay.This report is for one (1) impactor f/pfna blade.(b)(4).

Manufacturer Narrative

Device returned to manufacturer.The subject device has been received and the product evaluation is in progress.No conclusion can be drawn.Date received by manufacturer was inadvertently reported as november 6, 2017 on medwatch report (b)(4).The correct date should have been november 15, 2017.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.

Manufacturer Narrative

: device was used for treatment, not diagnosis.Device history record review.Part number: 03.010.410.Synthes lot number: 9120066.Release to warehouse date: 21.Oct.2014.Manufacturing site: (b)(4).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.A product development investigation was performed for the subject device (impactor, part number 03.010.410, lot number 9120066).The subject device was returned with the complaint condition stating the laser weld on top of the handle is broken.Therefore the handle is separated from the shaft.The evaluation has shown that the device is in a used condition, there are marks of hammer blows visible at the shaft, on the blue handle and the bottom side of the overhang with the attach/lock marking.The complaint is confirmed the most probable root cause is that the damages at the bottom side of the instrument lead to the breakage of the weld.Due to other complaints of the same nature, appropriate relevant actions have been taken to address the issue 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: IMPACTOR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7114326
• MDR Text Key: 95598230
• Report Number: 8030965-2017-50631
• Device Sequence Number: 1
• Product Code: HWA
• UDI-Device Identifier: 07611819349476
• UDI-Public: (01)07611819349476(10)9120066
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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,Followup
• Report Date: 11/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2017
• 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: 9120066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2014
• 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
• Patient Age: 89 YR
• Patient Weight: 70