MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US REV FEM/TIB/SLEEVE CLAMP; KNEE INSTRUMENT : CLAMPS

Catalog Number	217863134
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that intraoperatively during a surgery with a short-term-loaner kit, the surgeon found the reamer to be blunt and the clamp jammed.This caused a surgery prolongation of about 15 minutes.In addition, while trying to remove the blunt reamer from the machine, the surgeon's hand was hit by the machine (non-depuy product), and he subsequently complained of pain.
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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : according to the information received, "intraoperatively during a surgery with a short-term-loaner kit the surgeon found the reamer to be blunt and the clamp jammed.This caused a surgery prolongation of abput 15 minutes.In addition, while trying to remove the blunt reamer from the machine, the surgeon´s hand was hit by the machine (not depuy-product) , and he subsequently complained of pain." the product was not returned to medtech orthopaedics, however photos were provided for review.The photo investigation did not reveal that rev fem/tib/sleeve clamp (217863134) had an functionality issue.The evidence provided was not sufficient to confirm the reported event.Functionality issues cannot be evaluated through photo investigation.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was not confirmed as the observed condition of the rev fem/tib/sleeve clamp would not contribute to the complaint about the 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 : product description: rev fem/tib/sleeve clamp product code: 217863134.Lot number: tbwuk.Quantity manufactured: (b)(4) date of manufacture: 2018-08-21.Any anomalies or deviations identified in dhr: none.Expiry date: n/a.Ifu reference:" 090200721 rev j.A manufacturing record evaluation was performed for the finished device (product code:217863134, lot: tbwuk), and no non-conformances / manufacturing irregularities were identified.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information received, "intraoperatively during a surgery with a short-term-loaner kit the surgeon found the reamer to be blunt and the clamp jammed.This caused a surgery prolongation of about 15 minutes.In addition, while trying to remove the blunt reamer from the machine, the surgeon´s hand was hit by the machine (not depuy-product), and he subsequently complained of pain." the product was returned to j&j medtech orthopaedics for evaluation.Visual inspection revealed the overall surface of rev fem/tib/sleeve clamp with signs of heavy usage.A dimensional inspection was not performed since it was not applicable to the complaint condition.A functional test was performed and revealed resistance on the metal hinge component while opening and closing.Galling is suspected to have internally occurred, causing the internal metal components to begin to seize.Per the instruction for use, ifu-0902-00-721 rev.J, all moving parts must be thoroughly cleaned and lubricated with a water-soluble lubricant.However, based on the aspect of the device, the observed condition was identified as an end of life indicator; damage consistent with repeated use and servicing.The lifecycle requirements of the device are event related and depend on the use and inspection of the device in clinical practice.As the device can be damaged on the first or 100th use, the device must be properly inspected prior to each surgical use.Refer to the device/country specific ifu for information related to end of life, reprocessing instructions, and inspection procedures.The overall complaint was confirmed as the observed condition of the rev fem/tib/sleeve clamp would have contributed to the complained device issue.Based on the investigation findings, the potential cause is traced to end of life, and it has been determined that no corrective and/or preventative action is required.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 - 1) quantity manufactured: (b)(4).2) date of manufacture: 2018-08-21.3) any anomalies or deviations identified in dhr: none.4) expiry date: n/a.5) ifu reference:" 090200721 rev j.Device history review: 1) quantity manufactured: (b)(4).2) date of manufacture: 2018-08-21.3) any anomalies or deviations identified in dhr: none.4) expiry date: n/a.5) ifu reference:" 090200721 rev j.

• Brand Name: REV FEM/TIB/SLEEVE CLAMP
• Common Device Name: KNEE INSTRUMENT : CLAMPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 22043579
• Report Number: 1818910-2025-08097
• Device Sequence Number: 8908576
• Product Code: HXD
• UDI-Device Identifier: 10603295096238
• UDI-Public: (01)10603295096238(10)TBWUK
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,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: 217863134
• Device Lot Number: TBWUK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2025
• Supplement Date Received by Manufacturer: 07/04/2025; 07/11/2025
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 07/07/2025; 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2018
• 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