MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.0MM TI LOCKING SCR SLF-TPNG WITH STARDRIVE RECESS 12MM; PLATE,FIXATION,BONE

Catalog Number 401.882S

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/05/2020

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: the device has been 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, the patient underwent the open reduction internal fixation (orif) surgery for ulnar distal end fractures by using the locking screw.During the surgery, the surgeon tried to engage the locking screw with the lcp distal ulna plate at the most proximal hole, but the locking screw did not engage with the plate and could not be locked.The surgeon tried to engage the locking screw with the plate three times while checking insertion direction by referring to a template, but he could not lock the screw.The surgeon used another screw to complete the surgery.The surgery was completed successfully.The patient was reported as stable.Concomitant device reported: lcp distal ulna plate (part number unknown, lot unknown, quantity 1), screwdriver (part number unknown, lot unknown, quantity 1).This report involves one (1) 2.0mm ti locking scr slf-tpng with stardrive recess 12mm.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.This mre review is for sterilization procedure only: part: 401.882s, lot: l847772, manufacturing site: selzach, supplier: früh verpackungstechnik ag, release to warehouse date: april 10, 2018, expiry date: april 1, 2028.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Non-sterile part was manufactured in mezzovico.Part: 401.882, lot: l835858, manufacturing site: mezzovico, release to warehouse date: march 26, 2018.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the received screw was found deformed at the threaded section at the screw-head.The anodized layer is worn away at the damages which indicates that they were caused post-manufacturing.All features related to the reported complaint condition were reviewed and no other issues were identified.Dimensional inspection: the relevant feature is deformed in a manner which prevents accurate measurement of the feature.Document / specification review: the manufacturing review shows that the production procedure was according to the specifications and there were no issues that would contribute to this complaint condition.Summary: our investigation has shown, that the reported complaint condition is confirmed due to the damaged thread flanks.Because of the damage, it is not possible to measure the relevant dimension.This damage is clearly caused post manufacturing considering the evidence that anodized layer is partially disappeared.We assume that the involved screws were not inserted aligned into the corresponding counterpart hole during insertion procedure.By this situation the thread got inevitable damaged which resulted in the malfunction of the device.Finally we conclude that the cause of failure is not due to any manufacturing non-conformance's.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.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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: 2.0MM TI LOCKING SCR SLF-TPNG WITH STARDRIVE RECESS 12MM
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10173378
• MDR Text Key: 195725802
• Report Number: 8030965-2020-04309
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819929104
• UDI-Public: (01)07611819929104
• Combination Product (y/n): N
• PMA/PMN Number: K063049
• 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: 06/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 401.882S
• Device Lot Number: L847772
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2020
• Initial Date Manufacturer Received: 06/07/2020
• Initial Date FDA Received: 06/19/2020
• Supplement Dates Manufacturer Received: 07/16/2020
• Supplement Dates FDA Received: 08/05/2020
• Patient Sequence Number: 1
• Treatment: UNK - PLATES; UNK - SCREWDRIVERS; UNK - PLATES; UNK - SCREWDRIVERS
• Patient Age: 79 YR