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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. GENTLE THREADS INTERFERENCE SCREW 7X20MM ROUND HEAD SCREW, FIXATION

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ZIMMER BIOMET, INC. GENTLE THREADS INTERFERENCE SCREW 7X20MM ROUND HEAD 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 07/24/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). The commingled product that was inside of the package was part#: (b)(4), lot#: 625450, manufacture date: october 19, 2017, sterile expiry date: (b)(6) 2022. Udi # : (b)(4). (b)(4). 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.

 
Manufacturer Narrative

This follow-up report is being submitted to relay additional information. 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.

 
Event Description

No further event information available at the time of this report.

 
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Brand NameGENTLE THREADS INTERFERENCE SCREW 7X20MM ROUND HEAD
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 Key7800885
MDR Text Key117720759
Report Number0001825034-2018-08296
Device Sequence Number1
Product Code HWC
Combination Product (Y/N)N
Reporter Country CodeFR
PMA/PMN NumberPK041274
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,Followup
Report Date 10/29/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/21/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number905612
Device LOT Number611330
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 Manufactured10/10/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-3176-2018

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