MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK INSTRUMENT CASE; INSTRUMENT CASES

Catalog Number UNK INSTRUMENT CASE

Device Problem No Apparent Adverse Event (3189)

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

Event Date 11/07/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).The device catalog number is unknown; therefore, udi is unavailable.(b)(4).Investigation summary: no device associated with this report was received for examination.The investigation could not verify or draw any conclusions about the root cause of the reported event without the device to examine.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Upon arrival to musgrove park hospital for an elective attune revision with noiles femur, i was informed by the surgeon that the plan was to perform a full attune revision total knee replacement, with a noiles femur required as second option.The scrub practitioner had already prepared all attune revision instrumentation and the patient was in the anaesthetic room.Whilst discussing the plan with the scrub practitioner i recognised that the some of the instrumentation required for a noiles femur with attune tibia were not present.I contacted sterile services, who confirmed these instruments were unsterile.I then contacted my senior colleagues to confirm other available options should a noiles femur be required however there was no feasible outcome.I immediately informed the surgeon where it was agreed it was not safe to go ahead with surgery.

• Brand Name: UNK INSTRUMENT CASE
• Type of Device: INSTRUMENT CASES
• 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: 15932563
• MDR Text Key: 304982558
• Report Number: 1818910-2022-24583
• Device Sequence Number: 1
• Product Code: FSM
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 12/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK INSTRUMENT CASE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention