MAUDE Adverse Event Report: SYNTHES GMBH 2.4MM TI VA LOCKING SCREW STARDRIVE 18MM STERILE; SCREW, FIXATION, BONE

Catalog Number	04.210.118TS
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from japan reports an event as follows: it was reported that on (b)(6)2023, the patient underwent an unknown surgery.During the procedure, the most distal hole of the 2-hole plate malfunctioned and could not be locked.The 2-hole plate was replaced with a 3-hole plate, and a drill guide was used without a guiding block.The va-hole area seemed to be crushed.The procedure was completed successfully with no surgical delay.There was no adverse patient impact, their status is stable.No fragments were generated, it was confirmed via x-ray that no pieces were present in the patient¿s body.No further information is available.This report is for a 2.4mm ti va locking screw stardrive 18mm sterile.This is report 2 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.H10 additional narrative: d2: additional procode: hrs e3: initial reporter is a synthes employee.H3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing 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.
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.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Sterile part: 04.210.118ts sterile lot no: 132l007 release to warehouse date: 27 jan 2023 expiry date: 01 jan 2028 manufacturing site: werk selzach supplier: (b)(4).A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Non-sterile part: 04.210.118 non-sterile lot: 852p769 manufacturing site: werk selzach release to warehouse date: 27 may 2022 supplier: (b)(4).The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that had the head threads stripped.The allegation can be confirmed.A dimensional inspection for the device was unable to be performed due to post manufacturing damage.The observed condition of the device was consistent with a component failure that may have been caused by exposure to unintended forces.The overall complaint was confirmed as the observed condition of the va lockscr ø2.4 self-tap l18 tan would contribute to the complained device issue.Based on the investigation findings, and 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.

• Brand Name: 2.4MM TI VA LOCKING SCREW STARDRIVE 18MM STERILE
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK SELZACH; bohnackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18939724
• Report Number: 8030965-2024-03833
• Device Sequence Number: 15143789
• Product Code: HWC
• UDI-Device Identifier: 10886982262615
• UDI-Public: (01)10886982262615
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K103243
• 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,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
• Operator of Device: Health Professional
• Device Catalogue Number: 04.210.118TS
• Device Lot Number: 132L007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/11/2024
• Supplement Date Received by Manufacturer: 04/01/2024
• Initial Report FDA Received Date: 03/20/2024
• Supplement Report FDA Received Date: 04/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2023
• 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: UNK - GUIDES/SLEEVES/AIMING: GUIDE; VA-LCP-2-COLUMN DRP2.4 VOLAR NARR LE SHA
• Patient Sex: Unknown