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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HEADLESS TROCAR DRILL PIN 3.2 MM DIAMETER 75 MM LENGTH PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. HEADLESS TROCAR DRILL PIN 3.2 MM DIAMETER 75 MM LENGTH PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Migration (4003)
Patient Problem No Code Available (3191)
Event Date 09/29/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). Foreign (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product has been discarded. 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 knee arthroplasty a pin was noted on an intraoperative x-ray to have migrated into the patient's soft tissue. The operation was delayed by 90 minutes while waiting for another surgeon to assist in removing the pin.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information. The event was confirmed with x-rays received. Review of the x-rays found metallic pin lying within the soft tissues posterior to the knee. Depending on the location of the pin (medial, lateral, central), which can not be determined on this single view, there could be damage to neurovascular structures such as the popliteal artery/vein or the sciatic nerve branches. Dhr was reviewed and no discrepancies relevant to the reported event were found. As stated in persona partial knee system surgical technique, when using any headless trocar pin, it is important to leave 10 mm or more of the pin exposed. This will allow for ease of removal when using the pin puller. The root cause of the reported event is attributed to use error. 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
No further event information available at the time of this report.
 
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Brand NameHEADLESS TROCAR DRILL PIN 3.2 MM DIAMETER 75 MM LENGTH
Type of DevicePROSTHESIS, KNEE
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 Key10656325
MDR Text Key210634855
Report Number0001822565-2020-03479
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K182964
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number00590102000
Device Lot Number64468941
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/05/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/26/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 10/09/2020 Patient Sequence Number: 1
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