MAUDE Adverse Event Report: SYNTHES GMBH UNIVERSAL CHUCK; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	03.043.001
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2025
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.
Event or Problem Description
It was reported that the t handle chuck was found to be broken.There were no 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.H3, h6: the product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device revealed that the component chuck of the universal chuck was found jammed.No cosmetic damage was observed, suggesting that the cause of the defect may have within the internal components.Based on the available evidence, a definitive root cause could not be determined.A functional evaluation was performed to rotate the chuck to the left and right.However, it could not be turned.As a result, the jaws could not be opened.Therefore, the reported condition can be confirmed.A dimensional inspection was not performed as it is not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the universal chuck 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 j&j medtech orthopaedics 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.Device history lot : part # 03.043.001 lot # 21616202 manufacturing site: werk selzach logistik release to warehouse date: 09.Nov.2022 expiration date: n/a supplier: - (b)(4).A manufacturing record evaluation was performed for the finished article lot 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.
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: h6 component codes: most relevant component code is g07002 (appropriate term/code not available) to capture no findings available due to no product returned.H6 photo investigation: the product was not returned to medtech orthopaedics; however, photos were provided for review.The photo investigation of " 03.043.001, universal chuck" can not revealed the reported condition.As, the provided evidence is not sufficient to identify that which part of the device handle is broken.Based on the available evidence, a definitive root cause could not be determined.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was not confirmed as the observed condition of the universal chuck 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.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of medtech orthopaedics 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.Device history lot: part # 03.043.001.Lot # 21616202.Manufacturing site: werk selzach logistik.Release to warehouse date: 09.Nov.2022.Expiration date: n/a.Supplier: (b)(4).A manufacturing record evaluation was performed for the finished article lot 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.
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: added: a3a (sex) and d4 (expiration date) corrected: g1 and h4 if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: UNIVERSAL CHUCK
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• 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: 21874392
• Report Number: 8030965-2025-03702
• Device Sequence Number: 8631396
• Product Code: LXH
• UDI-Device Identifier: 10886982297372
• UDI-Public: (01)10886982297372(10)21616202
• Combination Product (Y/N): N
• 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,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: 03.043.001
• Device Lot Number: 21616202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/26/2025
• Supplement Date Received by Manufacturer: 04/22/2025; 05/16/2025; 05/20/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 04/28/2025; 05/19/2025; 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2022
• 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: 3008812560-12/14/2021-00
• Patient Sequence Number: 1
• Patient Sex: Unknown