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

Model Number N/A

Device Problem Fitting Problem (2183)

Patient Problem No Information (3190)

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.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay correction of information.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.

• Brand Name: PTN2 SS INSERTION JIG 128-DEG
• Type of Device: TRAUMA - 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 Key: 6935311
• MDR Text Key: 90303679
• Report Number: 0001825034-2017-07435
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 14-456545
• Device Lot Number: 632500
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/16/2014
• Initial Date FDA Received: 10/10/2017
• Supplement Dates Manufacturer Received: 10/16/2014
• Supplement Dates FDA Received: 04/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1