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

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: 498003, bmp sleeve grip crimper, mmx1772, the 498003, bmp sleeve grip crimper, mmx1915.(b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-00754, 0001825034-2018-00753.

Event Description

It was reported that the instrument was found broken.No further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected information.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and corrected information.The complaint samples were evaluated and the reported event was confirmed through physical evaluation.The returned devices underwent fracture analysis and hardness testing.All devices were identified to be fractured near the base, however lot mmx1877 (finished goods item (b)(4), lot 336650) was also identified to be missing a hinge pin.All visible fracture artifacts for the three (3) devices suggest a bending overload failure, however, the devices were in conformance with specifications.The device history records were reviewed and no discrepancies were identified.Based on available information, a definitive root cause cannot be determined.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.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.

• Brand Name: BMP SLEEVE GRIP CRIMPER
• Type of Device: CRIMPER, PIN
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7262818
• MDR Text Key: 100021292
• Report Number: 0001825034-2018-00755
• Device Sequence Number: 1
• Product Code: HXQ
• Combination Product (y/n): N
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2018
• 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: 336650
• Other Device ID Number: (01) 00880304009608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2018
• Date Manufacturer Received: 07/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1