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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET TRAUMA AFFIXUS HIP FRACTURE NAIL 125 DEG 9MM X 180MM ROD, FIXATION

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BIOMET TRAUMA AFFIXUS HIP FRACTURE NAIL 125 DEG 9MM X 180MM ROD, FIXATION Back to Search Results
Model Number N/A
Device Problems Failure to Disconnect (2541); Device Operational Issue (2914)
Patient Problem No Code Available (3191)
Event Date 06/28/2017
Event Type  Injury  
Manufacturer Narrative
This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch. Product has been returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information. Corrected: model #/lot #: lot number: 153150 or 153160, expiration date: apr 25, 2027 or apr 24, 2027. Complaint sample was evaluated and the reported event was confirmed. The returned device is one 125-degree affixus hip fracture nail, pn 814309180 ln 5550103, along with the associated 125-degree targeting jig and connecting bolt. Visually, the nail and jig are unremarkable, with a small amount of cosmetic wear likely due to implantation, explantation, and sterilization. The connecting bolt shows wear - but not to the point of being stripped. Functional testing reveals the bolt to be fused to the nail, confirming this complaint. The lot number etched on the device, 5550103, corresponds to the component part 814309180-00. A review of manufacturing records shows that this was issued to two finished goods lots of item 814309180, lot 153150 and lot 153160. Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found. Review of the complaint history determined that no further action(s) is/are required. 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.
 
Manufacturer Narrative
(b)(4). Medical product - insertion jig 125 degree, cat#: 211201200 lot#: e73df4. Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-05191 and 0001825034-2017-05197.
 
Event Description
It was reported that during a hip fracture nailing procedure, the connecting jig bolt was locked in the nail and could not be dislodged or removed. As a result, the entire system had to be removed from the patient. A competitor product was used to complete the procedure with minimal delay. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameAFFIXUS HIP FRACTURE NAIL 125 DEG 9MM X 180MM
Type of DeviceROD, FIXATION
Manufacturer (Section D)
BIOMET TRAUMA
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
BIOMET ORTHOPEDICS
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key6739504
MDR Text Key109930768
Report Number0001825034-2017-05191
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
PK100238
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/25/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number814309180
Device Lot NumberSEE H10 NARRATIVE
Other Device ID Number(01) 00887868037962
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/11/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/08/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/09/2016
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: 07/25/2017 Patient Sequence Number: 1
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