MAUDE Adverse Event Report: SYNTHES GMBH 2.4/2.7MM VA-LCP TMT FUSION PLATE; PLATE, FIXATION, BONE

Catalog Number	02.211.266
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that patient underwent a midfoot fusion procedure on (b)(6) 2024.The distal right locking hole failed to lock the variable angle (va) locking screw.It was the third plate used in the case and the second screw in the plate.The other screws and plates had no issues.After trying to get the screw out to replace it with something else, the surgeon pulled the plate out to get the screw out as the screw just kept spinning in the locking hole.It was replaced with a cloverleaf fusion plate instead.Procedure was completed successfully with a delay of approximately twenty minutes.There was no patient consequence.This report is for a 2.4/2.7mm va-lcp tmt fusion plate.This is report 1 of 2 for (b)(4).
Additional 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.Additional narrative: d2: additional procode: hwc h3, h6: product code: 02.211.266 lot: 7613p53 release to warehouse date: 01 september 2023 expiration date: na supplier: (b)(4).Manufacturing site: werk selzach logistik a manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.The device associated with this report was returned to depuy synthes for evaluation.Visual analysis of the returned sample found the the internal threads on the locking hole stripped.The observed condition of the device was consistent with a component failure that may have been caused by exposure to unintended forces while usage.A dimensional inspection was unable to be performed due to post manufacturing damage.A functional test was performed attempting to rotate the screw into the plate and it was hardly possible due to the observed stripped damage.The complaint condition was able to be replicated.The overall complaint was confirmed as the observed condition of the va lockscr ø2.7 head 2.4 self-tap l22 ss would have contributed to the complained issue.Based on the investigation findings, the potential cause is traced to component failure, and it has been determined that no corrective and/or preventative action is required.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.The drawings reflecting the current and manufactured revisions were reviewed.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: 2.4/2.7MM VA-LCP TMT FUSION PLATE
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 19967630
• Report Number: 8030965-2024-09876
• Device Sequence Number: 15693784
• Product Code: HRS
• UDI-Device Identifier: 10886982054760
• UDI-Public: (01)10886982054760(11)230901(10)7613P53
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K100776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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
• Operator of Device: Health Professional
• Device Catalogue Number: 02.211.266
• Device Lot Number: 7613P53
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/16/2024
• Initial Report FDA Received Date: 08/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L22 SS
• Patient Age: 37 YR
• Patient Sex: Male