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

Model Number	287432
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exact date of event is unknown; event reported occurred on an unknown date in 2019.Complainant part is not expected to be returned for manufacturer review / investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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
Device report from mitek (b)(4) reports an event as follows: it was reported that the omnicut 4.2 res blade 5pk duo+ had metal abrasion.It is unknown if there was a surgical delay due to the reported event.The procedure was completed successfully.It was noted fragments were generated but it is unknown if or how they were removed.There was no reported consequence to the patient.This is report 1 of 1 for (b)(4).
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 the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h6: 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.

• 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: 8950069
• Report Number: 1221934-2019-58162
• Device Sequence Number: 2860072
• Product Code: HRX
• UDI-Device Identifier: 10886705022496
• UDI-Public: (01)10886705022496
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K130912
• 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): 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 Model Number: 287432
• Device Catalogue Number: 287432
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/26/2019
• Supplement Date Received by Manufacturer: 09/09/2019
• Initial Report FDA Received Date: 08/30/2019
• Supplement Report FDA Received Date: 09/17/2019
• Patient Sequence Number: 1