MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MODULAR FLEXDRILL BIT 3.2X30; HIP INSTRUMENT

Model Number N/A

Device Problem Fracture (1260)

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

Event Date 01/14/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source (b)(6).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.

Event Description

It was reported that during a hip procedure, the drill bit broke upon contact.Another drill was used to complete the surgery.No known adverse event was reported.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

No additional event information to report at this time.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.Visual inspection identified that the drill bit fractured into two pieces.The device exhibited circumferential grooves and damage on the shank.The cutting edges were dull and damaged.Dimensional analysis was not performed as the damage was too severe.Dhr 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: MODULAR FLEXDRILL BIT 3.2X30
• Type of Device: HIP INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8964288
• MDR Text Key: 156720527
• Report Number: 0001822565-2019-03819
• 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
• Report Date: 09/25/2019

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: 00879000703
• Device Lot Number: 62848576
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/16/2019
• Initial Date FDA Received: 09/05/2019
• Supplement Dates Manufacturer Received: 09/17/2019
• Supplement Dates FDA Received: 09/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNKNOWN SCREW