MAUDE Adverse Event Report: SYNTHES GMBH VA LOCKSCR ø2.7 HEAD 2.4 SELF-TAP L58 TA; SCREW, FIXATION, BONE

Catalog Number	04.211.058S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
J&j medtech is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which j&j medtech has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, j&j medtech or its employees that the report constitutes an admission that the device, j&j medtech, or its employees caused or contributed to the potential event described in additional narrative: 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
It was reported the surgeon noted that some metal material shavings came out when he inserted the screws intraoperatively.Surgery date is unknown.It is unknown if there was surgical delay or how the procedure was completed.No known patient consequences.
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.H11 additional narrative: corrected: g1 h6 component codes: most relevant component code is g07002 (appropriate term/code not available) to capture no findings available due to no product returned.H3, h6: product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.Device history lot part:04.211.058s lot:386l569 manufacturing site: werk selzach supplier: (b)(4) release to warehouse date:15 apr 2025 expiration date: 01 apr 2035.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.If additional information is made available, the investigation will be updated as applicable.
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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: VA LOCKSCR ø2.7 HEAD 2.4 SELF-TAP L58 TA
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach CO ; SZ
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 22193988
• Report Number: 8030965-2025-05878
• Device Sequence Number: 15887708
• Product Code: HWC
• UDI-Device Identifier: 10886982119216
• UDI-Public: (01)10886982119216(17)350401(10)386L569
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,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: 04.211.058S
• Device Lot Number: 386L569
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/20/2025
• Supplement Date Received by Manufacturer: 06/16/2025; 06/25/2025
• Initial Report FDA Received Date: 06/12/2025
• Supplement Report FDA Received Date: 06/20/2025; 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/15/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CORTSCR ø3.5 SELF-TAP L22 TAN.; LWPROF METAPHYS COMPRES SCR ø2.7 SELF-TA.; LWPROF METAPHYS COMPRES SCR ø2.7 SELF-TA.; VA LOCKSCR ø2.7 HE 2.4 SELF-TAP L26 TAN.; VA LOCKSCR ø2.7 HE 2.4 SELF-TAP L34 TAN.; VA LOCKSCR ø2.7 HE 2.4 SELF-TAP L38 TAN.; VA LOCKSCR ø2.7 HE 2.4 SELF-TAP L46 TAN.; VA LOCKSCR ø2.7 HE 2.4 SELF-TAP L54 TAN.
• Patient Sex: Unknown