MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BMP SLEEVE GRIP CRIMPER; CRIMPER, PIN

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/03/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source, foreign ¿ events occurred in (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during use, the tip of the instrument broke; however, the surgery took place normally.No adverse events have been reported as a result of the malfunction.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The complaint sample was evaluated and the reported event was confirmed through physical evaluation.Visual analysis of the returned device confirmed it to be fractured at the tip, however, further examination of the fracture was unable to be performed as the device appears to have been welded back together.The device was additionally subjected to energy-dispersive x-ray spectroscopy and confirmed to be in conformance with product specifications.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information provided.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: BMP SLEEVE GRIP CRIMPER
• Type of Device: CRIMPER, PIN
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7252519
• MDR Text Key: 99899579
• Report Number: 0001825034-2018-00403
• Device Sequence Number: 1
• Product Code: HXQ
• Combination Product (y/n): N
• Reporter Country Code: LE
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 498003
• Device Lot Number: 082320
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/23/2001
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1