MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 5.0MM PERIPR VA LCKNG SCREW SLF-TPNG/STRDRV/14MM-STER; IMPLANT,FIXATION DEVICE, CONDYLAR PLATE

Catalog Number 02.231.014S

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/07/2020

Event Type  malfunction  

Manufacturer Narrative

Additional procode: hrs, hwc.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 synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020 during an unknown procedure, the periprosthetic screw would not screw into the locking plate.There was no patient consequence.There was no surgical delay.The procedure outcome was not reported.Concomitant device reported: unknown plates: trauma (part# unknown, lot# unknown, quantity 1).This report is for one (1) 5.0mm peripr va locking screw slf-tpng/strdrv/14mm-ster.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.H3, h6: part: 02.231.014s, lot: 9018237, manufacturing site: mezzovico, release to warehouse date: june 24, 2014, expiry date: june 01, 2024.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the visual inspection has shown that the periprosthetic screw has flattened thread flanks and nicks on the entire shaft.In general, the screw is in a used condition with various burrs all over.Dimensional inspection: screw checked per drawing.Outside diameter shaft (thread) pass outside diameter head (thread) pass total length: pass.Document/specification review: drawing was reviewed during this investigation.The returned screw was manufactured in june 2014 according to the specifications.The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements with no non-conformities noted.Summary: our investigation has shown that the complaint condition is confirmed as the device was found damaged.While no definitive root cause could be determined, it is possible that misalignment event has taken place during insertion.Misalignment takes place when the connection between the involved parts are not parallel or not angular.This situation increases friction along the bearing surfaces and can turn into a damage and can compromise the functionality of the device.The parts conformed to dimensional specification at the time of manufacturing and passed inspection requirements.The relevant dimensions were measured and found according to the specification.Therefore, we can confirm the visible damages are not from any manufacturing non-conformity.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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.

Event Description

This is report 1 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.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: 5.0MM PERIPR VA LCKNG SCREW SLF-TPNG/STRDRV/14MM-STER
• Type of Device: IMPLANT,FIXATION DEVICE, CONDYLAR PLATE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10778909
• MDR Text Key: 214369414
• Report Number: 8030965-2020-08513
• Device Sequence Number: 1
• Product Code: JDP
• UDI-Device Identifier: 07611819447394
• UDI-Public: (01)07611819447394
• Combination Product (y/n): N
• PMA/PMN Number: K110354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.231.014S
• Device Lot Number: 9018237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Date Manufacturer Received: 12/04/2020
• Patient Sequence Number: 1
• Treatment: UNK - PLATES; UNK - PLATES