MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US GLOBAL AP EXTRACTION HANDLE; EXTREMITY INSTRUMENTS : HANDLES

Model Number 2130-01-075

Device Problems Break (1069); Unintended Movement (3026)

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

Event Date 01/15/2022

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

It was reported that during a hip revision of a pinnacle cup two impaction handles snapped off the back during insertion of the replacement cup.The impactor sheered the rotating knob on the back of the impactors.Four set are available in house so surgical delay was no more than 5 minutes to bring up replacements.No patient known consequences surgery was completed otherwise without incident.Additional during a cleaning of the global ap set the ap broach extractor was noted to be damaged.The handle still functions but the weld appear to have broken and the handle now freely spins.No surgical involvement.

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 : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: GLOBAL AP EXTRACTION HANDLE
• Type of Device: EXTREMITY INSTRUMENTS : HANDLES
• 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: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13366103
• MDR Text Key: 288502083
• Report Number: 1818910-2022-01725
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10603295090588
• UDI-Public: 10603295090588
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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
• Report Date: 01/27/2022

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
• Device Operator: Health Professional
• Device Model Number: 2130-01-075
• Device Catalogue Number: 213001075
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2022
• Initial Date FDA Received: 01/27/2022
• Supplement Dates Manufacturer Received: 03/04/2022
• Supplement Dates FDA Received: 03/07/2022
• 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: Unknown
• Patient Sequence Number: 1