MAUDE Adverse Event Report: SYNTHES GMBH RATCHET T-HANDLE WITH LOW TOGGLE-6MM HXC; SCREWDRIVER

Catalog Number	03.620.005
Medical Device Problem Code	Material Integrity Problem (2978)
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
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.Additional narrative: h3, h6: per franchise complaint product investigation procedure is for complaints for which a non-manufacturing related probable cause has been identified' no manufacturing record evaluation is required.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 the green rubber that cover the ratchet t-handle w/low toggle w/hex-coup was cracked and a fragment is broken from the top part.The fragment was not received and no other issues were identified.A dimensional inspection for the ratchet t-handle w/low toggle w/hex-coup was not performed due to post manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.However, with the evidence provided a complete potential cause can not be established.A functional test for the ratchet t-handle w/low toggle w/hex-coup was not performed as it is not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the ratchet t-handle w/low toggle w/hex-coup would have contributed to the complained device issue.Based on the investigation findings, 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.Only the current drawing revision was reviewed: - t-handle, ratchet 6mm hex coupler, push-action.
Event or Problem Description
It was reported that on an unknown date, the plastic/rubber coating is cracking and peeling away, spd refuses to process item.There was no patient consequence reported.

• Brand Name: RATCHET T-HANDLE WITH LOW TOGGLE-6MM HXC
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 24335260
• Report Number: 8030965-2026-01522
• Device Sequence Number: 9791036
• Product Code: HXX
• UDI-Device Identifier: 07611819824072
• UDI-Public: (01)07611819824072(10)562337B06
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• 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: 03.620.005
• Device Lot Number: 562337B06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 02/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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