MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DVR PEG DRIVER FAST 2.0MM; DRIVER, PROSTHESIS

Model Number N/A

Device Problems Fracture (1260); Device Slipped (1584)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint number - (b)(4).Initial reporter: - exact hospital information for this event is unknown, however, it was relayed that it could have occurred at the following: (b)(6).Possible surgeon's relayed for this event are also as follows: (b)(6).Report source: foreign - (b)(6).Product has been received by zimmer biomet and the investigation is in progress.

Event Description

It is reported the driver slipped/fractured while screwing or unscrewing during surgery.A surgical delay of greater than 30 minutes, to retrieve a secondary driver, has been reported for this issue; however, it is unclear at this time if this occurred during this event.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual analysis confirms that 3 of these are fractured, and 12 are stripped.Three devices from the returned samples were subjected to microscopic analysis and material characterization.The report concludes that the fractured drivers showed indications of overload fracture by exhibiting ductile dimples.The stripped drivers showed deformed corners.Eds elemental analysis shows that all samples were consistent with product specifications.Device history record was reviewed and no discrepancies relevant to the reported event 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: DVR PEG DRIVER FAST 2.0MM
• Type of Device: DRIVER, PROSTHESIS
• 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: 7028774
• MDR Text Key: 91935452
• Report Number: 0001825034-2017-10242
• Device Sequence Number: 1
• Product Code: HWR
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: FPD20
• Device Lot Number: DBW271650
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2017
• Initial Date FDA Received: 11/14/2017
• Supplement Dates Manufacturer Received: 04/25/2018
• Supplement Dates FDA Received: 04/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Hospitalization