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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HFN 130 DEG 9MM X 180MM ROD, FIXATION

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ZIMMER BIOMET, INC. HFN 130 DEG 9MM X 180MM ROD, FIXATION Back to Search Results
Model Number N/A
Device Problem Separation Failure (2547)
Patient Problem No Information (3190)
Event Date 12/04/2017
Event Type  malfunction  
Manufacturer Narrative
This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch. It is unknown with which lot number pn: 814509180 was released to. It is one of the following possible lot combinations: lot# 118760, sterile expiration date: may 1, 2027. Lot# 099480, sterile expiration date: apr 23, 2027. Lot# 099470, sterile expiration date: apr 22, 2027. Medical product: insertion jig bolt, cat#: 211201202 lot#: e28dv4. Hfn 130 deg 9mm x 180mm, cat#: 814509180 lot#: 118760, 099480, or 099470. T-handle hudson, cat#: 281001004 lot#: fa7n74. Insertion jig 130 degree, cat#: 211201201 lot#: e73dg4. Flexible jig bolt driver 8mm, cat#: 281013037 lot#: nm1210. 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. Udi # (b)(4). Complaint sample was evaluated and the reported event was not confirmed. The visual evaluation revealed that the jig bolt driver was noted to be fractured. The jig was removed from the nail with an allen wrench with minimal effort. Once removed, it was noted that the threads of both the jig bolt and the nail are undamaged, and the bolt and nail are able to assemble and disassemble as expected. Device history record was reviewed and no discrepancies were found. The 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.
 
Event Description
No further event information available at the time of this report.
 
Manufacturer Narrative
(b)(4). Multiple mdr's were submitted for this event. Please see report(s): 0001825034 - 2018 - 00494. Concomitant medical products: unknown part/lot; jig bolt, 281001004 t-handle hudson, lot fa7n74, 281013037 flexible jig bolt driver 8mm, lot nm1210, 211201201 insertion jig 130 degree, lot e73dg4. Product has been received by zimmer biomet and the investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported the bolt would not release during removal of the jig. The nail was removed after a 15 minute delay to surgery and the bolt was able to release. No further information is available at this time.
 
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Brand NameHFN 130 DEG 9MM X 180MM
Type of DeviceROD, FIXATION
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key7238650
MDR Text Key286913066
Report Number0001825034-2018-00495
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
PK100238
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Type of Report Initial,Followup,Followup
Report Date 01/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number814509180
Device Lot NumberSEE H10
Other Device ID NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/16/2018
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 02/02/2018 Patient Sequence Number: 1
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