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

Model Number N/A

Device Problem Fracture (1260)

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

Event Date 06/13/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.

Event Description

It is reported that the product fractured during the surgery.Attempts have been made, however, no further information is available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

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

Event Description

It is reported that the product fractured during the surgery.Attempts have been made, however, no further information is available at this time.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Report source : foreign: europe: france.Complaint sample was evaluated and the reported event was confirmed.Inspection of the returned device revealed that the jaw of the instrument is fractured.The fractured surface shows artifacts that suggest a bending overload fracture.Material analysis and hardness check determined the product is conforming to specifications.Device history record was reviewed and no discrepancies were found.Root cause was unable to 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.

• Brand Name: BMP SLEEVE GRIP CRIMPER
• Type of Device: TRAUMA, INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7778599
• MDR Text Key: 117006041
• Report Number: 0001825034-2018-04855
• Device Sequence Number: 1
• Product Code: HXQ
• Combination Product (y/n): N
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 498003
• Device Lot Number: 637670
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/28/2018
• Initial Date FDA Received: 08/13/2018
• Supplement Dates Manufacturer Received: 08/31/2018; 09/26/2018; 05/07/2019
• Supplement Dates FDA Received: 09/21/2018; 10/23/2018; 05/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 56 YR