MAUDE Adverse Event Report: STRYKER INSTRUMENTS-PUERTO RICO BIO-PREP BONE PREPARATION KIT; PROSTHESIS, HIP, CEMENT RESTRICTOR

Catalog Number 0206710000

Device Problem Fracture (1260)

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

Event Date 06/30/2022

Event Type  malfunction  

Manufacturer Narrative

This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events 1 event was reported for this quarter.Product return status 1 device investigation type has not yet been determined.Additional information 1 device was labeled for single-use.1 device was not reprocessed or reused.

Event Description

This report summarizes 1 malfunction event in which the device or cutting accessory fractured.1 event had patient involvement; no patient impact.

Event Description

This report summarizes 1 malfunction event in which the device or cutting accessory fractured.1 event had patient involvement; no patient impact.

Manufacturer Narrative

This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.1 previously reported event is included in this follow-up record.Product return status 1 device was not available for evaluation.H3 other text : device not available.

• Brand Name: BIO-PREP BONE PREPARATION KIT
• Type of Device: PROSTHESIS, HIP, CEMENT RESTRICTOR
• Manufacturer (Section D): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo 00615 ; * 00615
• Manufacturer (Section G): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo 00615 ; * 00615
• Manufacturer Contact: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 15108065
• MDR Text Key: 304028806
• Report Number: 3015967359-2022-01516
• Device Sequence Number: 1
• Product Code: JDK
• UDI-Device Identifier: 34546540039638
• UDI-Public: 34546540039638
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 0206710000
• Device Lot Number: VMSR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/30/2022
• Was Device Evaluated by Manufacturer?: No
• 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