MAUDE Adverse Event Report: SYNTHES GMBH LOCKSCR ø2.4 SELF-TAP L14 TAN; SCREW, FIXATION, BONE

Catalog Number	412.814TS
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2023
Type of Reportable Event	Malfunction
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.D2b: additional product code: hrs.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.
Event or Problem Description
Device report from synthes reports an event in japan as follows: it was reported that on december 19, 2023, the patient underwent an orif surgery for a distal radius fracture.When inserting the ti locking screw into the diaphysis, it was difficult to engage with the t8 screwdriver and the threads of the screw stripped.The same size screw was used, but so was that one.The screwdriver was changed, but the situation remained the same.The surgeon inserted a va locking screw 2.4 14mm and completed the surgery with no problems within 30 minutes delay.There is also a possibility that the threads of the t8 screwdriver may stripped.Patient status/ outcome: stable.No broken fragments were retained in the patient.No further information is available.This report is for one (1) lockscr ã¸2.4 self-tap l14 tan this is report 2 of 3 for complaint (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.H3, h6: a product investigation was conducted.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 stripped from the threaded head.The reported allegation can be confirmed.No other defect was found.This issue can be related to the unable to assemble issue, therefore 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 lockscr ã¸2.4 self-tap l14 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.H3, h6: a manufacturing record evaluation was performed for the finished device product code : 412.814ts, lot number# 3586p12.It was electronically reviewed and no nonconformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 09-jan-2023, manufacturing site:jabil grenchen, expiry date:01-dec-2027.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: LOCKSCR ø2.4 SELF-TAP L14 TAN
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK GRENCHEN (CH); solothurnstrasse 186; grenchen CO 2540 ; SZ 2540
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18495347
• Report Number: 8030965-2024-00720
• Device Sequence Number: 3554350
• Product Code: HWC
• UDI-Device Identifier: 10886982211613
• UDI-Public: (01)10886982211613
• 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: 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
• Operator of Device: Health Professional
• Device Catalogue Number: 412.814TS
• Device Lot Number: 3586P12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2023
• Supplement Date Received by Manufacturer: 03/06/2024
• Initial Report FDA Received Date: 01/11/2024
• Supplement Report FDA Received Date: 03/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2023
• 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: SCRDRIVER SHAFT 2.4 SHORT SELF-HOLDING F
• Patient Sex: Unknown