MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TRIAL IMPLANT HANDLE NON STERILE; TEMPLATE

Catalog Number SFW565R

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

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.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, the prodisc-l (pdl) mallet and pdl trial handle were reported broken.The pdl mallet/hammer has missing plastic tips and the pdl trial handle has a defect which was not visible.It is unknown when the issue was observed.There was no procedure nor patient involvement.This report is for a trial implant handle.This is report 1 of 1 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.A device history record (dhr) review was conducted: part number: sfw565r, lot number: t107779, manufacturing site: tuttlingen, release to warehouse date: 14-mar-2016 ((b)(4) devices) and 28-mar-2017 ((b)(4) devices).A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.The raw material certificate was reviewed and the used material was according to the specification of the device.A product investigation was conducted.Visual inspection: the device shows wear and tear signs allover the surface.There are heavy hammer marks on the top of the device.Furthermore the laser weld between the handle and the shaft was found cracked.No breakage could be observed, therefore this complaint will be rated as unconfirmed.Function test: the returned device was tested by customer quality (b)(4) with a corresponding counterpart and was found functional as per design intended.No functional issue detected.Summary: our investigation has shown that the complaint condition is unconfirmed.Due to the heavy wear and tear signs, we can assume that this product was often and intensive used.We do suppose that the device encountered unintended forces, such as being dropped on the floor and/ or excessive force application during its use, which finally resulted in cracking of the welding.As the returned device passed the functional check we conclude that the cause of failure is not due to any manufacturing non-conformance's.The root cause was identified during the performed cq evaluation and therefore the in the investigation flow listed remaining investigation steps are not required.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 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: TRIAL IMPLANT HANDLE NON STERILE
• Type of Device: TEMPLATE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8609239
• MDR Text Key: 145114458
• Report Number: 8030965-2019-63937
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 07611819175488
• UDI-Public: (01)07611819175488
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 04/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SFW565R
• Device Lot Number: T107779
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2019
• Date Manufacturer Received: 05/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1