MAUDE Adverse Event Report: DEPUY MITEK OMNICUT 5.2 (USED W/ MICRO HANDPIECE) MITEK FMS BLADES & BURRS

Catalog Number 283346

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/06/2017

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. (b)(4). The lot expiration date is currently unavailable.

Event Description

On using onmicut blade, metal shavings broken off into shoulder joint additional information received via email from the affiliate on 2-21-2017. What type of procedure was this? arthroscopic subacromial decompression were all the shavings removed from the patient? all visible shavings were removed what was used to remove the shavings? suction did this delay the procedure, and if so how long? five to 10 minutes.

Manufacturer Narrative

The complaint device was received and evaluated. When observed under magnification, the inner shaft showed signs of friction between the two shafts. The friction marks indicate excessive force, which could lead to metal shavings as reported, confirming the complaint. A possible root cause would be improper use of blade/bur such as too much force, speed, blade/bur selection on tissue type. A dhr review has been conducted and our results indicate that this batch of product was processed without incident related to this complaint and therefore there is no evidence of manufacturing anomalies on the paperwork reviewed. Further, a review into the depuy synthes mitek complaints system revealed no similar complaint of any kind for this lot of devices that were released to distribution. A white paper was performed previously on this failure; the result indicated that the amount of shedding for this product is acceptable. At this point in time, no further action is warranted. However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field. Udi: (b)(4).

• Brand Name: OMNICUT 5.2 (USED W/ MICRO HANDPIECE)
• Type of Device: MITEK FMS BLADES & BURRS
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jennifer lawrence ; 325 paramount drive; raynham, MA 02767 ; 5089776860
• MDR Report Key: 6382562
• MDR Text Key: 69202619
• Report Number: 1221934-2017-10096
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041824
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 02/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 10/31/2017
• Device Catalogue Number: 283346
• Device Lot Number: A1211001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Report to Manufacturer: 02/06/2017
• Date Manufacturer Received: 04/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2013
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Patient Treatment Data

Date Received: 03/06/2017 Patient Sequence Number: 1