MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP BIO-PREP BONE PREPARATION KIT; PROSTHESIS, HIP, CEMENT RESTRICTOR

Catalog Number 0206710000

Device Problem Fracture (1260)

Patient Problem Obstruction/Occlusion (2422)

Event Date 04/30/2021

Event Type  Injury  

Manufacturer Narrative

Device not returned.

Event Description

It was reported that during a left reverse total shoulder arthroplasty for repair of a humerus fracture, the inserter handle became stuck in the canal, which was noted as narrow, and the cement restrictor broke.The surgeon cut and reamed the canal free.The procedure was completed following an unspecified delay.Post-operatively the patient has developed arterial occlusion requiring vascular consultation.

• Brand Name: BIO-PREP BONE PREPARATION KIT
• Type of Device: PROSTHESIS, HIP, CEMENT RESTRICTOR
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo 00615 ; * 00615
• Manufacturer Contact: zach baker ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 12192935
• MDR Text Key: 262402127
• Report Number: 3015967359-2021-01442
• Device Sequence Number: 1
• Product Code: JDK
• UDI-Device Identifier: 34546540039638
• UDI-Public: 34546540039638
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K931847
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0206710000
• Device Lot Number: 21060012
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2021
• 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
• Patient Outcome(s): Required Intervention