MAUDE Adverse Event Report: SYNTHES GMBH 2.4MM TI VA-LCP VOLAR RIM DSTL RADIUS PLATE/6H HD/5H SHAFT/L; PLATE, FIXATION, BONE

Catalog Number 04.115.751S

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

Patient Problem Muscle/Tendon Damage (4532)

Event Type  Injury  

Manufacturer Narrative

Additional product code: hwc.Complainant part is not expected to be returned for manufacturer review/investigation.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, the patient underwent revision surgery to remove the plate and place the palmaris longus tendon at the tear and suture the tendon.Open reduction internal fixation for distal radius fracture took place on (b)(6), with the plate in question.On (b)(6), 2021 the patient visited the hospital and said that it was inconvenient because she had been unable to move her fingers for about 2 weeks.At that time, rupture of the flexor pollicis longus tendon was found.The revision surgery was completed successfully with no surgical delay, was 150 minutes long and incision was 14cm.The surgeon commented that, one of the causes of this tear was that the reduction at the initial surgery was not so good and the plate was not placed in a good position.This report is for one (1) 2.4mm ti va-lcp volar rim dstl radius plate/6h hd/5h shaft/l.This is report 1 of 2 for complaint (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.Product complaint # (b)(4).Investigation summary : product was not returned.Based on the information available, it has been determined that no corrective and 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 history lot : part # 04.115.751s, lot # 65p4559, manufacturing site: mezzovico, release to warehouse date: 08 sept 2020, expiry date: 01.Aug.2030.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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 TI VA-LCP VOLAR RIM DSTL RADIUS PLATE/6H HD/5H SHAFT/L
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11651928
• MDR Text Key: 250167474
• Report Number: 8030965-2021-02794
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819461451
• UDI-Public: (01)07611819461451
• Combination Product (y/n): N
• PMA/PMN Number: K110125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 03/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.115.751S
• Device Lot Number: 65P4559
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/15/2021
• Initial Date FDA Received: 04/12/2021
• Supplement Dates Manufacturer Received: 04/19/2021
• Supplement Dates FDA Received: 05/17/2021
• Patient Sequence Number: 1
• Treatment: UNK - SCREWS: TRAUMA
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 52