MAUDE Adverse Event Report: SYNTHES GMBH 2.4MM TI VA-LCP 2-COL DSTL RAD PL NRW 6H HD/2H SHAFT/LT-STER; PLATE, FIXATION, BONE

Catalog Number 04.111.521S

Device Problems Device-Device Incompatibility (2919); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/26/2023

Event Type  malfunction  

Event Description

Device report from synthes reports an event in japan as follows: it was reported that on december 26, 2023, the patient underwent an unknown surgery.The most distal hole of the 2-hole plate malfunctioned and could not be locked.Therefore, the 2-hole plate was replaced with a 3-hole plate.This time, a drill-guide was used without a guiding block.The va-hole area seems to be crashed.The surgery was completed successfully with no surgical delay.No further information is available.This report is for one (1) unk - plates: distal radius.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).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.D1, d2a, d2b, d3, d4, g4 - 510k: this report is for an unk - plates: distal radius rfna/unknown lot.Part and lot numbers are unknown; udi number is unknown.D9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h4, h6: without a lot number the device history records review could not be completed.Product was not returned.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.

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 manufacturing record evaluation was performed for the sterile finished lot number, and no non-conformances were identified.Part number: 04.111.521s, lot number: 826p087, manufacturing site: mezzovico, release to warehouse date: 31 may 2022, expiration date: 01 may 2032.The device associated with this report was returned to depuy synthes for evaluation.Visual analysis of the returned sample revealed that there was no damage or defects with the va-lcp-2-column drp2.4 volar narr le sha.The reported allegation cannot be confirmed.A dimensional inspection was performed for the va-lcp-2-column drp2.4 volar narr le sha and met specifications.The overall complaint was unconfirmed as the observed condition of the va-lcp-2-column drp2.4 volar narr le sha would not contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.

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: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.

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.

Event Description

It was further reported the surgery was completed without any problems with implant fixation due to the use of an alternative.There are no pieces in the patient.The surgeon confirmed by x-ray.This report is for (1) 2.4mm ti va-lcp 2-col dstl rad pl nrw 6h hd/2h shaft/lt-ster.

• Brand Name: 2.4MM TI VA-LCP 2-COL DSTL RAD PL NRW 6H HD/2H SHAFT/LT-STER
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK MEZZOVICO (CH); via cavazz 5; mezzovico 6805 ; SZ 6805
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18534037
• MDR Text Key: 333115839
• Report Number: 8030965-2024-01008
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819392236
• UDI-Public: (01)07611819392236
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K092556
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.111.521S
• Device Lot Number: 826P087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - GUIDES/SLEEVES/AIMING: GUIDE; VA LOCKSCR Ø2.4 SELF-TAP L18 TAN