MAUDE Adverse Event Report: SYNTHES GMBH 2.4MM VA-LCP VOLAR RIM DISTAL RAD PL/6H HD/5H SHFT/RT-STER; PLATE, FIXATION, BONE

Catalog Number 02.115.750S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Rupture (2208); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/ investigation.Reporter is a j & j sales consultant.(b)(4).A device history record (dhr) review was conducted: part: 02.115.750s, lot: 3l08424, manufacturing site: (b)(4), release to warehouse date: 05.Feb.2019, expiry date: 01.Jan.2029.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/ or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 there was a postoperative rupture of fpl tendon.Rupture of flexor policis longus due to open reduction internal fixation (orif).There is no further information reported.Concomitant devices reported: va locking screw stardrive® ø 2.4 mm (part # 02.210.112ts, lot # unknown, quantity 5).This report is for one (1) 2.4mm va-lcp volar rim distal rad pl/6h hd/5h shft/rt-ster.This is report 1 of 6 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: 2.4MM VA-LCP VOLAR RIM DISTAL RAD PL/6H HD/5H SHFT/RT-STER
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10607437
• MDR Text Key: 209223785
• Report Number: 8030965-2020-07552
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819461406
• UDI-Public: (01)07611819461406
• Combination Product (y/n): N
• PMA/PMN Number: K110125
• 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: 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 02.115.750S
• Device Lot Number: 3L08424
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/28/2020
• Patient Sequence Number: 1
• Treatment: VA LOCKING SCREW STARDRIVE® Ø 2.4 MM, SE; VA LOCKING SCREW STARDRIVE® Ø 2.4 MM, SE; VA LOCKING SCREW STARDRIVE® Ø 2.4 MM, SE; VA LOCKING SCREW STARDRIVE® Ø 2.4 MM, SE; VA LOCKING SCREW STARDRIVE® Ø 2.4 MM, SE; VA LOCKING SCREW STARDRIVE® Ø 2.4 MM, SE; VA LOCKING SCREW STARDRIVE® Ø 2.4 MM, SE; VA LOCKING SCREW STARDRIVE® Ø 2.4 MM, SE; VA LOCKING SCREW STARDRIVE® Ø 2.4 MM, SE; VA LOCKING SCREW STARDRIVE® Ø 2.4 MM, SE
• Patient Outcome(s): Required Intervention