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

Catalog Number	283345
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4)-incomplete.Associated medwatch: 1221934-2018-54608.
Event or Problem Description
Metall abrasion.Patient consequence? no.Is the information being submitted for this complaint all the details that are known/available regarding this event? yes.Additional information from affiliate sept 5th 2018: the material shavings occurred just in the beginning of using it, the first minute.This failure didn't result in surgical delay of greater than 30 minutes or an inability to complete the procedure as intended.Fragments were retrieved with suction of shaver.The procedure was completed with the same device.Alternatives were readily available.There were no procedural or patient anatomy factors which may have contributed to the breakage.Surgical intervention was not planned.No particulates/shavings remained in the patient.No patient impact.
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.Udi: (b)(4).Associated medwatch: 1221934-2018-54608.
Event or Problem Description
It was reported during a knee arthroscopy metal abrasion/shavings occurred in the first minute of using the devices.The shavings were retrieved with the suction of the shaver; no shavings remained in the patient.The procedure was completed with the same device.No delay of greater than thirty (30) minutes was reported.It was noted alternatives were readily available.No procedure or patient anatomy fractures which may have contributed to the breakage was noted.No surgical intervention is planned; there was no impact to the patient.
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.Device was used for treatment, not diagnosis.H10 additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Evaluation statement: the device was received and evaluated.The device was reviewed by a cross functional team consisting of r&d, design quality, and supplier quality and it was visually and dimensionally inspected.The visual inspection revealed scratches on inside of outer assembly on the device.The scratches match location of teeth on inner assembly.Wear and scratches were observed on outside of inners and blades/edges of inner tip.As part of the functional test, the device was rotated and moved freely in both directions with no evidence of binding or resistance.All dimensional inspection were measured within tolerance.Machining, edm, welding, heat treat, and the electropolishing process were reviewed for other complaints with this similar defect with acceptable and no conclusive evidence that would have potential to contribute to this defect.Lot was not returned with the complaint, therefore review of this device specific to this complaint could not be completed.There were no areas of concern for how parts are handled through the manufacturing process that would have potential to contribute to this defect.There is no conclusive evidence from the investigation in to this issue currently.Hence, the root cause is undetermined.Investigation of this defect is in-process by cross-functional teams and will be documented within a non-conformance report.Udi: (b)(4).- incomplete depuy synthes has been informed that the lot number is not available.

• Brand Name: OMNICUT 4.2 RES BLADE 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: 7850919
• Report Number: 1221934-2018-54609
• Device Sequence Number: 11154842
• Product Code: HRX
• UDI-Device Identifier: 10886705022472
• UDI-Public: 10886705022472
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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,Followup
• Report Date (Section B): 08/10/2018

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: 283345
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2018
• Initial Date Received by Manufacturer: 08/10/2018
• Supplement Date Received by Manufacturer: 09/11/2018; 11/07/2018
• Initial Report FDA Received Date: 09/06/2018
• Supplement Report FDA Received Date: 10/04/2018; 11/08/2018
• Patient Sequence Number: 1