MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNIVERSAL INSERTER/EXTRACTOR

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 03/05/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).The consumer has indicated the device will be returned.Device not received as of yet.Once device is returned and investigation is completed, a supplemental medwatch 3500 a will be submitted.

Event Description

It was reported that the handle of instrument cracked (stem inserter), this occurred during surgery.The surgeon used a second impactor to perform surgery.No adverse event to patient reported.Additional information requested and received.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional 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.

Manufacturer Narrative

Instrument was returned and evaluated.Visual inspection of the returned device confirmed that the plastic handle is cracked.The marks found on the strike plate and shaft weldment of the inserter exhibit multiple dents, numerous impact marks and dings suggesting extensive use over the time.The approximate field age of the device is 22 years and 10 months.The frequency of use of the device is unknown.No significant damage was observed on the threaded tip.Likely root cause for the reported failure mode is due to normal wear over the course of use.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.

• Brand Name: UNIVERSAL INSERTER/EXTRACTOR
• Type of Device: EXTRACTOR
• 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: 7380736
• MDR Text Key: 103827524
• Report Number: 0001825034-2018-01819
• Device Sequence Number: 1
• Product Code: HWB
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/11/2018

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: Physician
• Device Model Number: N/A
• Device Catalogue Number: 31-473601
• Device Lot Number: 166821
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/05/2018
• Initial Date FDA Received: 03/29/2018
• Supplement Dates Manufacturer Received: 04/05/2018; 05/09/2018
• Supplement Dates FDA Received: 05/02/2018; 05/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/1995
• 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