MAUDE Adverse Event Report: SYNTHES GMBH INTER-LOCK SCREWDRIVER COMBINED T25/HEXA

Catalog Number	03.010.473
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported instrument 03.010.473 was defective in the loan set and could not be used during the procedure.Although there was no impact on the patient, this issue should have been identified during the inspection.The surgeon and the sales representative had to use an alternative instrument to proceed with the intervention.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary.The product was returned to j&j medtech orthopaedics for evaluation.The j&j medtech orthopaedics team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that inter-lock screwdriver combined t25/hexa was found stripped from the shaft tip and the sliding bar missing, causing the device to be unusable.A dimensional inspection and functional test for the inter-lock screwdriver combined t25/hexa were not performed due to post manufacturing damage.The stripped condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.Missing components may occur during the cleaning/sterilization process, particularly when the components are assembled or disassembled.As these procedures are often repeated, there is an increased risk of components going missing.However, without concrete evidence or further information, it is not possible to determine a root cause.The overall complaint was confirmed as the observed condition of the inter-lock screwdriver combined t25/hexa would contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.As part of j&j medtech orthopaedics quality process, all devices ar manufactured, inspected, and released to approved specifications.There is no indication that a design or manufacturing issue has caused the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Dimensional inspection: n/a.Device history review.Part number: 03.010.473-15.Lot number: 4475p77.Manufacturing site: hägendorf.Release to warehouse date: 10-may-2023.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: INTER-LOCK SCREWDRIVER COMBINED T25/HEXA
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): HÄGENDORF; im bifang 6; hägendorf 4614 ; SZ 4614
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 23392527
• Report Number: 8030965-2025-10724
• Device Sequence Number: 10015193
• Product Code: HXX
• UDI-Device Identifier: 07611819464049
• UDI-Public: (01)07611819464049(10)4475P77
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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: Foreign,Health Professional
• 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: 03.010.473
• Device Lot Number: 4475P77
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 10/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/10/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown