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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN DEPTH GAGE INSTRUMENTATION, HIP

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ZIMMER BIOMET, INC. UNKNOWN DEPTH GAGE INSTRUMENTATION, HIP Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/06/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Concomitant medical products: 00-6250-065-30 j6854352 bone screw 6. 5x30 selftap; 00-6250-065-25 j6829076 bone screw 6. 5x25 selftap; 31-323240 457210 3. 2mmx40mm rnglc+ acet drl bit; 110010273 6937512 g7 osseoti multihole 70mm i; 110031017 64844474 vivacit-e dm bearing 28x54mm; 00-6250-065-60 63469615 bone screw 6. 5x60 selftap; 00-6250-065-30 j6849822 bone screw 6. 5x30 selftap; 00-6250-065-50 j6910092 bone screw 6. 5x50 selftap; 110024467 457020 g7 dual mobility liner 54mm i; 31-323230 534180 3. 2mmx30mm rnglc+ acet drl bit. Reported event was confirmed by review of photographs received. Visual inspection of provided picture identified the gauge had fractured. 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. If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly. Zimmer biomet will continue to monitor for trends.
 
Event Description
It was reported that the depth gauge fractured during surgery. No adverse events have been reported as a result of the malfunction. Attempts have been made and additional information on the reported event is unavailable.
 
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Brand NameUNKNOWN DEPTH GAGE
Type of DeviceINSTRUMENTATION, HIP
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 Key12703549
MDR Text Key282392422
Report Number0001825034-2021-02972
Device Sequence Number1
Product Code HTJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Distributor
Reporter Occupation
Type of Report Initial
Report Date 10/26/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received10/06/2021
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

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