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

Catalog Number	283459
Medical Device Problem Code	Metal Shedding Debris (1804)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/02/2018
Type of Reportable Event	Malfunction
Additional 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) ¿ incomplete.The expiration date is not currently available.
Event or Problem Description
During the surgery the coating of the burr was getting loose in the ankle joint.They had to remove all the parts of the coating out of the joint.The patient was awake during the surgery and saw what was happening and asked the surgeon why all the coating parts were loose in his ankle joint.The surgeon had to explain what was happening with the burr during the surgery what makes it a very uncomfortable and unprofessional situation.After all the coating parts were removed the surgery finished well.Procedure was ankle arthroscopy and there was a 10 minutes delay.
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the complaint device was received and evaluated by npd and supplier quality.Visual observation under a magnification revealed, scratches in inside of outer blade, where inner base lines up.Chipping of metal on blades.Additionally chip on outer edge of outer assembly.Chipping and scratching of metal on same area of the blades.Preliminary discussions suggested that this was the result of the device hitting another hard object.A white paper was performed previously on this failure; the result indicated that the amount of shedding for this product is acceptable.The dhr review indicated that this batch of devices was processed with 1 incident not related to the complaint condition therefore, there is no evidence of manufacturing anomalies on the records reviewed.At this point in time, no corrective action is required and 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).
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch or first follow-up, a follow-up medwatch will be filed as appropriate.Udi: (b)(4) ¿ incomplete.The expiration date is not currently available.

• Brand Name: 4.0MM ROUND BURR PLUS 5PK
• Common Device Name: ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7392727
• Report Number: 1221934-2018-50394
• Device Sequence Number: 13720129
• Product Code: HRX
• UDI-Device Identifier: 10886705025428
• UDI-Public: 10886705025428
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K131191
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 283459
• Device Lot Number: M1707034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2018
• Initial Date Received by Manufacturer: 03/09/2018
• Supplement Date Received by Manufacturer: 04/30/2018; 04/30/2018
• Initial Report FDA Received Date: 04/03/2018
• Supplement Report FDA Received Date: 05/18/2018; 12/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1