MAUDE Adverse Event Report: DEPUY MITEK 5.0 MM BARREL BURR PLUS; ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE

Catalog Number	283869
Medical Device Problem Codes	Break (1069); Metal Shedding Debris (1804)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/12/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported by the affiliate that there was broken metal swarf into the shoulder joint on several occasions.The joint was cleaned out with suction.There was a five minute delay to the procedure.There was no patient harm.The case could be completed.
Event or Problem Description
It was reported by the affiliate that there was broken metal swarf into the shoulder joint on several occasions.The joint was cleaned out with suction.There was a five minute delay to the procedure.There was no patient harm.The case could be completed.The following information was obtained on 3-28-2018: the procedure was completed using alternative device.Alternatives were readily available.No further surgery required.The shaving/particles were flushed out and removed with suction with the best of ability.Product is no longer available to be returned.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.A review of the device history record indicated that this batch of product was released through an unrelated non-conformance with no link to the reported issue and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy synthes mitek complaints system revealed no other complaints of any kind for this lot of devices with the product code that were released to distribution.We cannot discern a root cause for the reported failure mode.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).

• Brand Name: 5.0 MM BARREL BURR PLUS
• Common Device Name: ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7338082
• Report Number: 1221934-2018-50297
• Device Sequence Number: 1852755
• Product Code: HRX
• UDI-Device Identifier: 10886705023080
• UDI-Public: 10886705023080
• Combination Product (Y/N): N
• PMA/510(K) Number: K041824
• 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
• Report Date (Section B): 02/16/2018

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: 06/30/2022
• Device Catalogue Number: 283869
• Device Lot Number: M1707029
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/16/2018
• Supplement Date Received by Manufacturer: 03/28/2018
• Initial Report FDA Received Date: 03/14/2018
• Supplement Report FDA Received Date: 04/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1