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U.S. Department of Health and Human Services

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

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BIOMET UK LTD. Q/CONNECT TWIST DRL 3.2MMX60MM FLUTED SURGICAL DRILL, REUSABLE Back to Search Results
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.

 
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Brand NameQ/CONNECT TWIST DRL 3.2MMX60MM
Type of DeviceFLUTED 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 Key9805042
MDR Text Key200813482
Report Number3002806535-2020-00121
Device Sequence Number1
Product Code HTW
Combination Product (Y/N)N
Reporter Country CodeUK
PMA/PMN NumberN/A
Number of Events Reported1
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 Received03/09/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number31-601114
Device LOT Number677661
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 Received03/19/2020
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 NumberN/A

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