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	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi: (b)(4) - incomplete the lot number is currently unavailable; therefore, the exp date is unavailable.The complaint was received and evaluated with npd.Visually the device seem to be in good condition, device seems unused.No obvious anomalies found.Functionally, when rotating the inner blade friction was felt.The inner blade was inspected, scratch marks were found on the inner hub.When inspecting the outer hub on the inside, a white substance was found, npd confirms this is the cause for the friction that occurs in the inner and outer hubs when the two blades are assembled together.The substance could not be identified, there a possible root cause could not be determined.At high rpms when device is used in the field the reported failure could occur.This complaint is confirmed.Furthermore, no lot number was supplied which precludes conducting a dhr review or a lot specific search in the complaints handling system and at this 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.
Event or Problem Description
It was reported by the affiliate in (b)(6) that the surgeon recognized that there was an abnormal metal noise when drilling the patient¿s bone during arcr surgery.Then, the error message was displayed and stopped working.During in-house engineering evaluation, it was determined that there was a white substance when inspecting the outer hub on the inside of the blade on the device.It was reported that the surgery was completed by using alternative device.It was not reported if there was a delay in the surgical procedure.It was reported that the device was brand new and on its first use when the issue occurred.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
Additional Manufacturer Narrative
Product complaint #: (b)(4).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 medwatch, a follow-up medwatch will be filed as appropriate.Correction: upon further review of the complaint, it was determined that the reported malfunction is unlikely to cause or contribute to serious injury or death if it were to recur.Therefore, this complaint is not reportable.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• 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: 8070968
• Report Number: 1221934-2018-55294
• Device Sequence Number: 1582353
• 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): 11/14/2018

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 Catalogue Number: 283469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2018
• Initial Date Received by Manufacturer: 11/14/2018
• Supplement Date Received by Manufacturer: 11/14/2018
• Initial Report FDA Received Date: 11/14/2018
• Supplement Report FDA Received Date: 11/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1