MAUDE Adverse Event Report: BIOMET ORTHOPEDICS BIOMET COMPREHENSIVE REVERSE SHOULDER- CENTREAL SCREW 6.5X30MM ST/NS; PROSTHESIS, SHOULDER

Catalog Number 115396

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/15/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It is reported that when the package was opened that a hair was present inside.A back up implant was utilized to complete the surgery.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the packaging of the returned part confirmed the presence of foreign material inside the tyvek pouch.The analysis identified that the ftir spectrum of the foreign material is consistent with being of biological origin; based on the appearance of the material it is likely a hair.Device history record was reviewed and no discrepancies were found.The root cause of the reported event is related to a manufacturing deficiency as the debris was likely introduced during manufacturing.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: BIOMET COMPREHENSIVE REVERSE SHOULDER- CENTREAL SCREW 6.5X30MM ST/NS
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6486811
• MDR Text Key: 72597416
• Report Number: 0001825034-2017-02512
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PK132239
• 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
• Report Date: 11/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 115396
• Device Lot Number: 770140
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1