MAUDE Adverse Event Report: SYNTHES GMBH 2.7MM VA-LCP DISTAL TIBIA T-PLATE/4 HOLES; PLATE, FIXATION, BONE

Catalog Number 02.118.306

Device Problem Device-Device Incompatibility (2919)

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

Event Date 11/20/2023

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2023, an orif ankle procedure was being performed.During the procedure, the surgeon had difficulty locking into the distal portion of the va-lcp posterior distal t plate.This caused an unknown surgical delay and required additional x-rays.The procedure was completed successfully using another plate and different sized screws.There was no adverse patient impact.No further information is available.This report is for a 2.7mm va-lcp distal tibia t-plate/4 holes.This is report 1 of 4 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.D2: additional procode: hwc.D9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.H3, h6: 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.

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H3, h4, h6 the product was not returned to depuy synthes, however photos were provided for review.The photo investigation was not able to find any visual or cosmetic damage that would contribute to the reported functional issue, however evidence of usage can be seen as the device shows what appears to be blood/tissue at the tip.Without the physical device a functional test cannot be performed.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was unconfirmed as the observed condition of the 2.7 va-lcp distal tibia t-plate/4 holes 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 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.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: 2.7MM VA-LCP DISTAL TIBIA T-PLATE/4 HOLES
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18329102
• MDR Text Key: 330967623
• Report Number: 8030965-2023-15714
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982038746
• UDI-Public: (01)10886982038746
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120854
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup

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: 02.118.306
• Device Lot Number: 5193P536
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/22/2023
• Initial Date FDA Received: 12/14/2023
• Supplement Dates Manufacturer Received: 01/18/2024
• Supplement Dates FDA Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 2.7 VA LCKNG SCR SLF-TPNG T8 SD REC 36.; 2.7 VA LCKNG SCR SLF-TPNG T8 SD REC 36.; 2.7 VA LCKNG SCR SLF-TPNG T8 SD REC 36.