MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK FIXATION PIN; KNEE INSTRUMENTS: FIXATION PIN

Catalog Number UNK FIXATION PIN

Device Problems Unstable (1667); Unintended Movement (3026)

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

Event Date 12/28/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (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

Problem reported: bailed case.Tibial array moved during resections.Caused software to shift and couldn't recover.System determined that the knee moved excessively because the array moved.This defect was noticed during pre op set up, not during intra op resections.No issue with system or hardware.When was the issue observed: pre-op.Troubleshooting: surgery had to go to a manual surgery.Reporter checked system via checkpoints and were shown to be visually off.Reporter reported that movement in the array caused the issue.No patient consequences or surgical delays all information has been disclosed.No further information was provided.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device was received for examination, therefore the reported event could not be confirmed.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will 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.

Manufacturer Narrative

Product complaint (b)(4).Added: h10 additional information.Sales rep clarification of event: "he states that he was involved in two events on the same day.The first event is a pre-op event of a damaged power cord (later found to be captured on (b)(4)).The second event (captured on this complaint) occurred when the surgeon's forearm bumped the array which caused the array, array clamp, and fixation pin to move.He states the patient had very poor bone quality.The system was unable to recognize the array at this point and so they made the decision to switch to manual.There was no patient harm that occurred and the surgery was successfully completed." 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.H10.

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 tibial array moved during resections.Caused the software to shift and could not recover.System determined that the knee moved excessively because the array moved.It was confirmed that there is no malfunction with the system but the event occurred when the surgeon's forearm bumped the array which caused the array, array clamp, and fixation pin to move.

• Brand Name: UNK FIXATION PIN
• Type of Device: KNEE INSTRUMENTS: FIXATION PIN
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS 1818910; 700 orthopaedic dr; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13315337
• MDR Text Key: 288584022
• Report Number: 1818910-2022-01397
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK FIXATION PIN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1