MAUDE Adverse Event Report: SYNTHES GMBH 2.4 VOLT(TM) TAP LOCKING SCREW TAP TO 90MM; TAP, BONE

Catalog Number	03.424.124
Medical Device Problem Codes	Material Integrity Problem (2978); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.H6 medical device problem code (a27) used to capture reportable malfunction related to recall.
Event or Problem Description
It was reported that tap ø2.4 tapping up to 90 l130 was associated with recall.The event involved a single device from this lot.There was no reported patient consequence or involvement, and the device was available for return.The complaint device was removed from use as a precaution.

• Brand Name: 2.4 VOLT(TM) TAP LOCKING SCREW TAP TO 90MM
• Common Device Name: TAP, BONE
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 24628370
• Report Number: 8030965-2026-02621
• Device Sequence Number: 15720442
• Product Code: HWX
• UDI-Device Identifier: 10886982335944
• UDI-Public: (01)10886982335944(10)68900P9
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,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: 03.424.124
• Device Lot Number: 68900P9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/08/2026
• Supplement Date Received by Manufacturer: 04/28/2026; 05/06/2026; 05/07/2026; 06/26/2026
• Initial Report FDA Received Date: 03/18/2026
• Supplement Report FDA Received Date: 05/01/2026; 05/06/2026; 05/07/2026; 06/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3015882686-02/18/2026-00
• Patient Sequence Number: 1
• Patient Sex: Unknown