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

Catalog Number	287869
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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.Udi: (b)(4) -incomplete.The expiration date is currently unavailable.
Event or Problem Description
During arthroscopy burr got stuck and could not be used anymore.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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 not returned by the customer therefore, device is not available for a physical evaluation.This complaint is not confirmed.It was reported that the device could not be used anymore.Possibly jammed during use.No further information regarding the procedure or the device used has been provided to determine a root cause for this failure.A device history record review was performed which indicated that there was a non-conformance related to the reported malfunction.All the issues identified were resolved prior to product release.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: BARREL BURR 5.0MM + DUO
• 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: 7609435
• Report Number: 1221934-2018-51981
• Device Sequence Number: 1555208
• Product Code: HRX
• UDI-Device Identifier: 10886705023097
• UDI-Public: 10886705023097
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 05/24/2018

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: 07/31/2022
• Device Catalogue Number: 287869
• Device Lot Number: M1708010
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/24/2018
• Supplement Date Received by Manufacturer: 12/21/2018
• Initial Report FDA Received Date: 06/18/2018
• Supplement Report FDA Received Date: 12/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1