MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 5 ACCOLADE II BROACH; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Model Number 1020-5205

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/24/2022

Event Type  Injury  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Event Description

It was reported that the broach handle attachment post on size 5 accolade 2 broach snapped off of the broach and was stuck in handle.Osteotomes and vice grips were used repeatedly to eventually remove the broach from the femoral canal.Surgery took roughly an additional hour to complete and surgeon had to remove some quality bone from patient¿s femur.

• Brand Name: SIZE 5 ACCOLADE II BROACH
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14731188
• MDR Text Key: 294586469
• Report Number: 0002249697-2022-00858
• Device Sequence Number: 1
• Product Code: KWL
• UDI-Device Identifier: 07613327252705
• UDI-Public: 07613327252705
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K153345
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• 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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1020-5205
• Device Catalogue Number: 1020-5205
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2022
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention