MAUDE Adverse Event Report: BIOMET UK LTD. Q/CONNECT TWIST DRL 3.2MMX60MM FLUTED SURGICAL DRILL, REUSABLE

Model Number N/A

Device Problems Break (1069); Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/22/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4). (b)(6). Report source, foreign - event occurred in (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation. 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 the left total hip replacement the drill tip broke and 35mm was left in situ. It was agreed not to remove tip from ischial bone as attempting to remove it would cause more bone and tissue damage.

• Brand Name: Q/CONNECT TWIST DRL 3.2MMX60MM
• Type of Device: FLUTED SURGICAL DRILL, REUSABLE
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 9805042
• MDR Text Key: 200813482
• Report Number: 3002806535-2020-00121
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (Y/N): N
• Reporter Country Code: UK
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: FOREIGN,OTHER
• Reporter Occupation: RISK MANAGER
• Type of Report: Initial,Followup
• Report Date: 03/25/2020

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 03/09/2020
• 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: 31-601114
• Device LOT Number: 677661
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 03/19/2020
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown
• Removal/Correction Number: N/A

Patient TREATMENT DATA

Date Received: 03/09/2020 Patient Sequence Number: 1