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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PTN2 SS INSERTION JIG 128-DEG TRAUMA - INSTRUMENTS

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ZIMMER BIOMET, INC. PTN2 SS INSERTION JIG 128-DEG TRAUMA - INSTRUMENTS Back to Search Results
Model Number N/A
Device Problem Fitting Problem
Event Date 10/14/2014
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). The complaint sample was evaluated and the reported event was not confirmed. The investigation and trials were completed at the same time as (b)(4). Functional testing of the returned (b)(4) was completed with assistance by the product design engineer, inserter functions to design intent, part left biomet conforming to drawing. Change to mating component was already in process and trial simulating revised mating component (reamer) passed, the complaint about binding prompted revision to the reamer. The complaint is considered valid and trial with old revision reamer duplicated customer issue. Device history record was reviewed and no discrepancies were found. Review of the complaint history determined that no further action is required as no trends were identified. Investigation results concluded that the reported event was due to the product being manufactured prior to a design change. 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

Reamer interfered with nail hole.

 
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Brand NamePTN2 SS INSERTION JIG 128-DEG
Type of DeviceTRAUMA - INSTRUMENTS
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 Key6935311
Report Number0001825034-2017-07435
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/03/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/10/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number14-456545
Device LOT Number632500
OTHER Device ID NumberN/A
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location Hospital
Date Manufacturer Received10/16/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/24/2014
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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