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

Model Number 86-5034

Device Problems Structural Problem (2506); Difficult to Open or Close (2921)

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

Event Date 05/17/2022

Event Type  malfunction  

Manufacturer Narrative

Product complaint # pc-(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Please review the ball joint caliper.There was no damage or delay in the surgery.No impact on surgery.

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 received.Please verify if there was any alleged device deficiency for the reported device? the lock button locks into position and does not unlock; this causes the clamp to not be opened and it is harder to remove it from the tissues.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary: device was returned for analysis.Examination of the returned instrument found the device to be fully functional.Therefore the complaint cannot be confirmed.A functional evaluation found the device was able to adjust, lock, and unlock as intended without restriction.The overall appearance of the device exhibited signs of heavy usage during its extensive time in the field.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation may be re-opened as necessary.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• 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: 14734576
• MDR Text Key: 297054002
• Report Number: 1818910-2022-11176
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295216599
• UDI-Public: 10603295216599
• Combination Product (y/n): N
• Reporter Country Code: PO
• 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: 06/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 86-5034
• Device Catalogue Number: 865034
• Device Lot Number: 5415663
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2001
• 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