MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH LARGE HANDLE WITH QUICK COUPLING; TAP,BONE

Catalog Number 311.431

Device Problem Device Difficult to Maintain (3134)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/18/2019

Event Type  malfunction  

Manufacturer Narrative

Part returned.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.A review of the device history record has been requested.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 reports an event in (b)(6) as follows: it was reported that on (b)(6), 2019, the patient underwent removal of tomofix due to bone healing.During the procedure, since it was difficult to use the handle of one (1) large handle with quick coupling, another one (1) handle large with quick coupling was used.The operation proceeded smoothly using the handle large with quick coupling.However, when the surgeon tried to remove the last locking screw that was at the most distal point of the plate, the handle large with quick coupling stripped the locking screw head.The surgeon then tried to remove the locking screw using one (1) conical extraction screw.However, the conical extraction screw broke, and the broken piece remained in the locking screw head.Due to this situation, a carbide drill could not be used.Finally, the surgeon extended the surgical incision largely (originally, the incision size was short.).Then, the surgeon could remove the screw somehow by rotating the plate.There was a forty-five (45) minutes of surgical delay.The procedure outcome and patient status were unknown.Concomitant device reported: tomofix tibial head plate (part#: 440.837s, lot#: unknown, quantity#: 1); unknown locking screws (part#: unknown, lot#: unknown, quantity# :unknown); handle large with quick coupling (part#: 03.010.516, lot#: unknown, quantity#: 1) this complaint involves three (3) devices.This report is 1 of 3 for (b)(4).

Event Description

Concomitant device reported: tomofix tibial head plate (part# 440.837s, lot# unknown, quantity# 1); unknown locking screws (part# unknown, lot# unknown, quantity# unknown); handle large with quick coupling (part# 03.010.516, lot# t156533, quantity# 1).

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.A device history record (dhr) review was conducted: part: 311.431, lot: 9949663, manufacturing site: bettlach, release to warehouse date: 23.May 2016.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.A product investigation was conducted.Visual inspection: the received handle is in a used condition with slight scratches.No other damages are visible.Functional test: an internal functional test with the returned extraction screw was performed.The complaint condition was in this constellation unconfirmed, as the extraction screw could be attached and detached to the handle as intended.Summary: the complaint condition could not be confirmed during the performed cq evaluation, and therefore the in the investigation flow listed remaining investigation steps are not required.The handle has passed the functional test as described above.Afterwards and with the provided information, it is not possible to determine the exact cause of the complained issue.We only can assume that during the operation an application error may have taken place.Therefore, we can confirm that the complaint condition is not from any manufacturing non-conformity.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: LARGE HANDLE WITH QUICK COUPLING
• Type of Device: TAP,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8791491
• MDR Text Key: 151119587
• Report Number: 8030965-2019-66248
• Device Sequence Number: 1
• Product Code: HWX
• UDI-Device Identifier: 07611819259836
• UDI-Public: (01)07611819259836
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 06/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 311.431
• Device Lot Number: 9949663
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• Date Manufacturer Received: 08/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR