MAUDE Adverse Event Report: BIOMET SPORTS MEDICINE FULL RADIUS DISPOSABLE SHAVER BLADE; ARTHROSCOPE

Catalog Number 908510

Device Problem Fracture (1260)

Patient Problems No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)

Event Date 12/14/2016

Event Type  Injury  

Manufacturer Narrative

(b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the device inner tip fractured during surgery.It was replaced for one of another size.No complications or delay were reported.No further information is available at this time.

Manufacturer Narrative

This follow-up report is being filed to relay additional information which was unknown at the time of the initial medwatch and corrected information.

Event Description

It was reported that during a knee arthroscopy procedure, the shaver blade inner tip fractured off into the patient.The pieces were retrieved from the patient with no further patient consequences reported.Another blade of a different size was utilized to complete the procedure.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Products were received as pn 908510 ln 935380 (qty.2).Products were visually examined.One of the returned shavers is fractured at the opening of the outer assembly and there are metal shavings visible where the fracture occurred.The second shaver is fractured farther down in the shaft and cannot be seen.Both products were disassembled and the fractures were more easily reviewed.The complaint files both mention that fragments fell into the patient but were retrieved.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action(s) is/are required.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: FULL RADIUS DISPOSABLE SHAVER BLADE
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): BIOMET SPORTS MEDICINE; 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: 6402016
• MDR Text Key: 69856155
• Report Number: 0001825034-2017-01537
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: PK920800
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 908510
• Device Lot Number: 935380
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2015
• 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
• Patient Outcome(s): Required Intervention