MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FLEXIBLE SILICONE DRILL DRIVER; INSTRUMENT

Model Number N/A

Device Problem Fracture (1260)

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

Event Date 01/17/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: (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.

Event Description

It was reported that the flexible drill had a split in the rubber and the internal mechanism seemed to be getting messy.This caused concern as to the ability to sterilize the device.Attempts were made to obtain additional information; however, none was available.

Manufacturer Narrative

Upon receipt of additional information, it has been determined that this device did not cause or contribute to a serious injury and was initially reported in error.The initial report was forwarded in error and should be voided.

Event Description

Upon receipt of additional information, it has been determined that this device did not cause or contribute to the reported event.The initial report was forwarded in error and should be voided.

• Brand Name: FLEXIBLE SILICONE DRILL DRIVER
• Type of Device: INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9687402
• MDR Text Key: 204380201
• Report Number: 0001825034-2020-00428
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 00880304569126
• UDI-Public: (01)00880304569126
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 05/11/2020

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: 110010733
• Device Lot Number: 150661
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/17/2020
• Initial Date FDA Received: 02/10/2020
• Supplement Dates Manufacturer Received: 05/08/2020
• Supplement Dates FDA Received: 05/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1