MAUDE Adverse Event Report: DEPUY MITEK LLC US AGGRESIVE 5.0MM 5PK; ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE

Catalog Number	283719
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/10/2019
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) via cst tool that the shaver terminal cutter aggressive 5.0 mm blade spread metal particles in to the joint while doing the shoulder arthroscopy.The procedure was completed by swapping out for another like device with no surgical delay in the procedure.Fragments were generated but were removed without additional intervention.There with no patient consequences.No other medical intervention was required.It was reported that the problem has only been with the engine terminal fms vue ref 283719 that released metal particles, the rest of the products worked perfectly and did not generate any type of failure.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
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 initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the complaint device was received and inspected.The complaint can be confirmed.A visual inspection was performed to determine if the device had any gross visual defects that may contribute to the complaint condition.It was observed that the surfaces of the inner blade and outer hub were scratched in the lateral direction.To test the functionality of the device, the inner blade was rotated in both directions.From this operation, no notable resistance was detected.Per the ifu, proper irrigation must be maintained while the device is in use.If proper irrigation is not maintained, excessive friction can occur between the inner blade and the outer hub therefore causing metal particulate shedding.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 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.Udi: (b)(4).

• Brand Name: AGGRESIVE 5.0MM 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: 8662306
• Report Number: 1221934-2019-57257
• Device Sequence Number: 2130680
• Product Code: HRX
• UDI-Device Identifier: 10886705022076
• UDI-Public: 10886705022076
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: 283719
• Device Lot Number: M1704011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/11/2019
• Supplement Date Received by Manufacturer: 06/11/2019
• Initial Report FDA Received Date: 06/03/2019
• Supplement Report FDA Received Date: 06/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1