MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ALPS HAND INSTRUMENT - DRIVER BIT; INSTRUMENT, TRAUMA

Catalog Number 231220211

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 02/27/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 2.0/2.5mm driver bit pn: 231220211 ln: 584001.Report source: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-01522.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.Product not returned.

Event Description

It was reported that during the procedure, the tip of the driver fractured inside the screw head.The screw and fractured piece were removed.

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.Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned product identified that the tip of both the drivers are fracture.The provided pictures show some screws which are stripped and fractured.It also seems like the broken tip of the driver jammed in the screw.Driver bit sample analyzed by sem showed that it suspected to have fractured due to torsional overload.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.

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.4112 is not applicable to this event.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: ALPS HAND INSTRUMENT - DRIVER BIT
• Type of Device: INSTRUMENT, TRAUMA
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8477486
• MDR Text Key: 140732158
• Report Number: 0001825034-2019-01520
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/05/2019

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: Health Professional
• Device Catalogue Number: 231220211
• Device Lot Number: 584001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/11/2019
• Initial Date FDA Received: 04/03/2019
• Supplement Dates Manufacturer Received: 07/05/2019; 07/05/2019
• Supplement Dates FDA Received: 07/05/2019; 07/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention