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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN BIOMET KIRSCHNER WIRE TRAUMA PROSTHESIS

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ZIMMER BIOMET, INC. UNKNOWN BIOMET KIRSCHNER WIRE TRAUMA PROSTHESIS Back to Search Results
Model Number N/A
Device Problems Fracture (1260); Difficult to Advance (2920)
Patient Problems Necrosis (1971); Device Embedded In Tissue or Plaque (3165)
Event Type  Injury  
Manufacturer Narrative

(b)(4). (b)(6). Reported event was unable to be confirmed as part number / lot number of device involved in the incident is unknown. Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided. 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

It was reported that during a trauma procedure, while trying to reduce and stabilize the fracture, the kirschner wire was not able to pierce the bone, which resulted in overheating with necrosis of the tissue. The wire eventually fractured while inside the patient. All of the fractured product was removed from the patient. The procedure was successfully finished with different zimmer biomet wires.

 
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Brand NameUNKNOWN BIOMET KIRSCHNER WIRE
Type of DeviceTRAUMA PROSTHESIS
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key7550707
MDR Text Key109484227
Report Number0001825034-2018-03505
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
Reporter Country CodeIT
PMA/PMN NumberPNI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 05/22/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/29/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
OTHER Device ID NumberN/A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/09/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 05/29/2018 Patient Sequence Number: 1
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