MAUDE Adverse Event Report: DEPUY MITEK LLC US BARREL TORNADO BURR 4.0MM 5PK ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE

Model Number 283489

Device Problems Mechanical Jam (2983); Suction Failure (4039)

Patient Problems Edema (1820); Not Applicable (3189)

Event Date 01/08/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint (b)(4). Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Udi: (b)(4).

Event Description

It was reported by affiliate via email, that during an arthroscopic shoulder surgery (subacromial decompression, clavicle resection) the shaver blad started to sound strange, had bad suction and stopped working. When the blade was taken out of the handpiece, the inner and outer parts were stuck together and could not be separated. The blade was replaced with a similar one, but the procedure was prolonged 15 min. The surgeon experienced a bit more swelling than normal.

• Brand Name: BARREL TORNADO BURR 4.0MM 5PK
• Type of Device: ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 9588543
• MDR Text Key: 187590111
• Report Number: 1221934-2020-00196
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K041824
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign

Reporter Occupation

• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/08/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 283489
• Device Catalogue Number: 283489
• Device Lot Number: M1907056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2020
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2019
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage