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

Catalog Number 03.010.410

Device Problem Device-Device Incompatibility (2919)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

Date of event is an unknown date in 2019.Reporter is a synthes employee.Device is not distributed in the united states, but is similar to device marketed in the usa.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.(b)(4).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 (b)(6) reports an event as follows: it was reported that on an unknown date in 2019, the inserted proximal fixation nail anti-rotation (pfna) blade locked but could not detach from the impactor.The surgeon decided to switch to trochanteric femoral nail advanced (tfna).Surgery was completed successfully with a delay of thirty (30) minutes.Patient status is unknown.Concomitant devices: pfna nail (part: 472.376s, lot: l833920, quantity: 1).This report is for an impactor for pfna blade.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: h4.H3, h6 investigation summary: investigation site: cq zuchwil.Selected flow: device interaction/functional visual inspection: the blade and the impactor were returned in assembled condition.The blade was in full attached position and was unlocked as required in this position, the blade did rotate freely as required.Functional test: it was possible to disassemble the devices during the investigation.Afterwards it was not possible to reproduce the complained malfunction with the disassembled devices.In the locked position could the blade be removed from the impactor as required.Also the blade could be attached to the impactor as required, as soon the blade was attached in the "attach" direction it was in unlocked condition and the tip was movable as required.Then it was possible to close the blade in the "lock" direction and the blade was finally locked and separated form the impactor as required.Summary: the complaint is unconfirmed as the devices are functional as required, it was not possible to reproduce the complained malfunction that the locked blade can not be detached from the impactor.The devices were received in assembled condition and the blade was unlocked as required the attached position.During the evaluation, it was possible to lock the blade and after the blade was locked it was not fixed to the impactor anymore as required.No malfunction of the received devices could be detected.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.Device history lot: part: 03.010.410.Lot: l432634.Manufacturing site: bettlach.Release to warehouse date: (b)(6)2017.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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: IMPACTOR F/PFNA BLADE
• Type of Device: IMPACTOR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9109317
• MDR Text Key: 159784311
• Report Number: 8030965-2019-68588
• Device Sequence Number: 1
• Product Code: HWA
• UDI-Device Identifier: 07611819349476
• UDI-Public: (01)07611819349476
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.010.410
• Device Lot Number: L432634
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2019
• Initial Date Manufacturer Received: 08/26/2019
• Initial Date FDA Received: 09/24/2019
• Supplement Dates Manufacturer Received: 10/17/2019
• Supplement Dates FDA Received: 11/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PFNA Ø11 SM 130° L200 TAN.; PFNA Ø11 SM 130° L200 TAN
• Patient Outcome(s): Required Intervention