MAUDE Adverse Event Report: ZIMMER BIOMET, INC. GLENOSPHERE FORCEPS; MANUAL SURGICAL INSTRUMENT

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/06/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent a reverse shoulder replacement.While the surgeon was holding the glenosphere for implantation into the glenoid, a hook on the end of the forceps fractured.The fracture created a surgical delay of 20 minutes.A different glenosphere impactor was used to complete the procedure.No pieces fell into the patient.No further information was provided.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.Product was visually examined.The product has seen heavy us as evident by the etching is fading and there are wear marks along the shaft.Corrosion was also observed in the interface between the two halves of the instrument as well as on the tips of the instrument.This indicates the instrument has been sterilized and used multiple times.Attention was turned to the tips of the instrument.Two of the four prongs have completely sheared off and a third prong has a large notch out of it.The fractured pieces were not returned with the instrument.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined.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: GLENOSPHERE FORCEPS
• Type of Device: MANUAL SURGICAL INSTRUMENT
• 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: 7082458
• MDR Text Key: 94300721
• Report Number: 0001825034-2017-10565
• Device Sequence Number: 1
• Product Code: HTD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2017
• 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: 406236
• Device Lot Number: 440310
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2013
• 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