MAUDE Adverse Event Report: DEPUY MITEK LLC US OMNICUT 4.2 RES BLADE 5PK DUO+; ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE

Catalog Number	287432
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).The lot number is unknown.
Event or Problem Description
It was reported by the affiliate via cst that omnicut 4.2 res blade 5pk duo+ has metal abrasion not more explained.The procedure was successfully completed with no patient harm.Fragments were generated.Additional information provided by the affiliate reported the lot number is unknown and the procedure occurred sometime in june; the exact procedure date is unknown.The affiliate also reported it is unknown if a surgical delay occurred and surgical intervention is not planned at the moment.It was reported that the case was completed with the same shaver.
Additional Manufacturer Narrative
Product complaint # (b)(4).Updated event description provided for reporting.Investigation summary the complaint device is not being returned, our affiliate informed us that it was discarded, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.One possible root cause for the reported problem could be excessive lateral force being applied to the device during use.However without the return of the complaint device, and no further information provided we cannot determine a definitive root cause.Further, no lot numbers were supplied which precludes conducting a dhr review or a lot specific search in the complaints handling system.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.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.
Event or Problem Description
9/3/2019: update: it was reported that the procedure was successfully completed with no patient harm.Fragments were generated and there is no definitive indication that fragments were retained in the patient.Should additional information become available, this event will be reassessed.
Event or Problem Description
Additional information reported by the affiliate stated it was unknown if generated fragments were removed.
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.H10 additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: OMNICUT 4.2 RES BLADE 5PK 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: 8813426
• Report Number: 1221934-2019-57733
• Device Sequence Number: 2196059
• Product Code: HRX
• UDI-Device Identifier: 10886705022496
• UDI-Public: 10886705022496
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K130912
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/26/2019

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 Catalogue Number: 287432
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 06/26/2019
• Supplement Date Received by Manufacturer: 08/13/2019; 09/03/2019
• Initial Report FDA Received Date: 07/22/2019
• Supplement Report FDA Received Date: 08/20/2019; 09/17/2019
• Patient Sequence Number: 1