MAUDE Adverse Event Report: DEPUY CMW 9610921 BIOSTOP G CEM RESTR 10MM; CEMENT / CEMENT ACCESSORY

Catalog Number 546310000

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 08/29/2016

Event Type  malfunction  

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.Udi: ((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 an endoprosthesis hip surgery when inserting the plug in the femoral canal, with the help of the proper instruments, it broke off.The broken piece was retrieved.

Manufacturer Narrative

The complaint states that during hip surgery, the biostop restrictor broke off despite the use of the proper instrumentation and had to be removed from the patient and replaced.As the product is not available for return, no photographs have been supplied and the product is manufactured externally, the investigation is limited as the product cannot be tested to assess if it works and/or to detect the fault.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

• Brand Name: BIOSTOP G CEM RESTR 10MM
• Type of Device: CEMENT / CEMENT ACCESSORY
• Manufacturer (Section D): DEPUY CMW 9610921; cornford rd; blackpool, lancashire FY4 4 QQ; UK FY4 4QQ
• Manufacturer (Section G): DEPUY CMW 9610921; cornford rd; blackpool, lancashire FY4 4 QQ; UK FY4 4QQ
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 5955986
• MDR Text Key: 54934200
• Report Number: 1818910-2016-27370
• Device Sequence Number: 1
• Product Code: JDK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K943727
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 546310000
• Device Lot Number: 15I2203013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 84 YR