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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. GENTLE THREADS INTERFERENCE SCREW 10X30MM FULL THREAD SCREW, FIXATION

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ZIMMER BIOMET, INC. GENTLE THREADS INTERFERENCE SCREW 10X30MM FULL THREAD SCREW, FIXATION Back to Search Results
Model Number N/A
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/02/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). The commingled product that was inside of the package was: part#: 905612, lot#: 611330, manufacture date: oct 10, 2017, sterile expiry date: oct 10, 2017, (b)(4). (b)(6). 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.

 
Event Description

It was reported that during surgery, it was noticed that a wrong product was found inside the package. The inner blister product identification labeling did not match what the outer carton device labeling stated. No impact to the patient or surgery was reported.

 
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Brand NameGENTLE THREADS INTERFERENCE SCREW 10X30MM FULL THREAD
Type of DeviceSCREW, FIXATION
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 Key7827235
MDR Text Key118589770
Report Number0001825034-2018-08462
Device Sequence Number1
Product Code HWC
Combination Product (Y/N)N
Reporter Country CodePL
PMA/PMN NumberPK982497
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN,HEALTH PR
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/15/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/29/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number905629
Device LOT Number625450
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/19/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/19/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-3177-2018

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