MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. IMP CBL DIA2 SS CABLE SLEEVE; CERCLAGE, FIXATION

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 10/19/2016

Event Type  Injury  

Manufacturer Narrative

The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.This user facility is outside of the united states.Current information is insufficient to permit a conclusion as to the cause of the event.This device is not distributed or manufactured in the united states; however, this report is being filed as zimmer biomet in (b)(4) manufactures a similar device under 510k number k982545.This report is number 1 of 2 mdr's filed for the same event (reference 3006946279-2016-00432 / 00433).Both products were used during the procedure and it is unknown which device fractured.

Event Description

During a revision surgery of a left hip prosthesis, the cable fractured during the cable tension adjustment.There was no patient injury or delay.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.(b)(4).Complaint sample was evaluated and the reported event was not confirmed.Evaluation of the returned devices found the 2 cables were not broken.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Investigation results concluded that the reported event was due to over-tensioning.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: IMP CBL DIA2 SS CABLE SLEEVE
• Type of Device: CERCLAGE, FIXATION
• Manufacturer (Section D): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• Manufacturer (Section G): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• Manufacturer Contact: elisabeth plane ; plateau de lautagne bp75; valence cedex ; 0334757591
• MDR Report Key: 6114043
• MDR Text Key: 60412060
• Report Number: 3006946279-2016-00432
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: PK982545
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/03/2020
• Device Model Number: N/A
• Device Catalogue Number: P0350806
• Device Lot Number: 0001002749
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 74 YR