MAUDE Adverse Event Report: SYNTHES GMBH RATCHET T-HANDLE 6MM HXC; PLIERS, SURGICAL

Catalog Number	388.652
Medical Device Problem Code	Compatibility Problem (2960)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2024, while the surgeon was placing the iliac screws for uss he changed and started using the ratchet handle.After a while the handle was not ratcheting and stopped working.The procedure was successfully completed with no surgical delay.No patient consequence was reported.This report involves one (1) ratchet t-handle 6mm hxc.This is report 1 of 1 for (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.H11 additional narrative: h3, h4, h6: part:388.652, synthes lot: h642265, supplier lot: h642265, release to warehouse date: sep 14, 2018, supplier: (b)(4).Ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Photos were provided for review.The photographs attached were reviewed, however in the images provided no observations pertaining to the nature of the reported event could be identified.The provided evidence was not sufficient to confirm the reported event of unable to assemble.Functionality issues cannot be evaluated through a photo investigation.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual inspection of the returned device found nothing indicative of a device nonconformance.No cosmetic damage was observed for the ratchet t-handle 6mm hxc.A partially functional test was performed, the sleeve slides correctly and the locking mechanism works properly in both directions.However, the mating device did not return, therefore, the reported condition could not be replicated.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed as the observed condition of the ratchet t-handle 6mm hxc would not contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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: RATCHET T-HANDLE 6MM HXC
• Common Device Name: PLIERS, SURGICAL
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 20043122
• Report Number: 8030965-2024-10246
• Device Sequence Number: 7895870
• Product Code: HTC
• UDI-Device Identifier: 10705034773681
• UDI-Public: (01)10705034773681(11)180914(10)H642265
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Physician
• 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: 388.652
• Device Lot Number: H642265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/25/2024
• Initial Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2018
• 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