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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET, INC. GENTLE THREAD 10X30MM FULL THR SCREW, FIXATION Back to Search Results
Model Number N/A
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Patient Involvement (2645)
Event Date 07/24/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Products were returned and reviewed. The label on the outer package does not match the label on the inner package; therefore, the complaint is confirmed and the product was comingled. Review of device history records found these units were released to distribution with no deviations or anomalies. Root cause is related to production & process control. 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. (b)(4). Additional concomitant medical products: 905612, gentle thread 7x20mm round hd, lot 611330. (b)(6). Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-08296.

 
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 THREAD 10X30MM FULL THR
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 Key8025229
MDR Text Key125760707
Report Number0001825034-2018-10107
Device Sequence Number1
Product Code HWC
Combination Product (Y/N)N
Reporter Country CodeFR
PMA/PMN NumberK041274
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN,HEALTH PR
Reporter Occupation
Remedial Action Recall
Type of Report Initial
Report Date 10/31/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/31/2018
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? Device Returned To Manufacturer
Date Returned to Manufacturer09/24/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/04/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/19/2017
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-3176-2018

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