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

Catalog Number	283469
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	05/18/2019
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).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported by the affiliate in (b)(6) that during an arthroscopic rotator cuff repair procedure the 4 mm barrel burr was working, but then there was a beep and the burr did not rotate.The surgeon detached the burr from the handpiece and recognized that the inner and outer burr was stuck.It was brand new and the first use when the issue occurred.There was less than a thirty minute surgical delay and no harm to the patient.There was patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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.Device was used for treatment, not diagnosis.Additional 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).Investigation summary: the complaint device was received and inspected.The complaint can be confirmed.It was observed that the inner and outer shaft of the device have been locked together.The device requires adequate irrigation to avoid tissue from building up inside the shaft while also remaining at a temperature during operation that will not damage the device.If adequate irrigation is not used, debris can build up in between the two shafts and the friction caused by the spinning shafts can induce heat transfer and cause the two parts to cold weld together.However, given the information provided we cannot discern a definitive root cause for the reported failure.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances related to the reported complaint condition were identified.At this point, 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.

• Brand Name: BARREL BURR 4.0MM 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: 8663687
• Report Number: 1221934-2019-57296
• Device Sequence Number: 16665757
• Product Code: HRX
• UDI-Device Identifier: 10886705022045
• UDI-Public: 10886705022045
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2019

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: 04/30/2023
• Device Catalogue Number: 283469
• Device Lot Number: M1805010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2019
• Initial Date Received by Manufacturer: 05/18/2019
• Supplement Date Received by Manufacturer: 06/12/2019
• Initial Report FDA Received Date: 06/03/2019
• Supplement Report FDA Received Date: 06/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1