MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*CALIBRATED PAT CUT GDE; KNEE INSTRUMENT : PATELLA HANDLE/CLAMPS

Catalog Number 865034

Device Problems Material Deformation (2976); Naturally Worn (2988)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/29/2024

Event Type  malfunction  

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 Description

It was reported that a portion of the resection was burred and damaged and the surgeon was unable to accurately establish the resection level required.He chose to do a free hand resection instead.Instrument was tagged for repair.No surgical delay, no patience consequence and no fragments generated.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary: according to the information received."portion of the resection was burred and damaged".The product was not returned to depuy synthes.However, photos were provided for review.The photo investigation revealed, that ' 865034, pfc*calibrated pat cut gde¿, had damages.The device exhibits damage consistent with repeated use.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.Since, the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed.As the observed, condition of the pfc*calibrated pat cut gde would contribute to the complained device issue.Based on the investigation findings, potential cause can be attributed to end of life identified.And 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 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.Device history lot: the device lot number is unknown.Therefore, a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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 Description

Additional information was received stating that the front portion of the measurement dial has numbers on it.We usually line up an etched line to the number reflecting the remnant of bone to be removed.This etched line was unable to be viewed as it would seem at some stage this has been burred by an oscillating saw and it is now unable to be seen.This burring did not occur in our case.This instrument was sent to us in this condition.

• Type of Device: KNEE INSTRUMENT : PATELLA HANDLE/CLAMPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18892901
• MDR Text Key: 337517231
• Report Number: 1818910-2024-05659
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295216599
• UDI-Public: 10603295216599
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 865034
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 60 KG