MAUDE Adverse Event Report: DEPUY MITEK LLC US OMNICUT 5.2 RES BLADE 5PK; ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE

Model Number	283346
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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)(6) reports an event as follows: it was reported that prior to a shoulder repair procedure the omnicut 5.2 reusable blade sterile packaging was damaged.There was no patient consequence.The procedure was able to be completed with no delay.Alternatives were readily available.This report is for a omnicut 5.2 reusable blade.This is report 2 of 2 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.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformities were identified.The complaint device was received and inspected.The complaint can be confirmed.The device was received inside the alleged damaged packaging.It was observed that the side of the thermoformed blister that is closest to the proximal end of the barrel burr was breached, and a circular portion seemed to have been punched off.Extensive root cause analysis from past investigations has revealed that this type of failure can occur when the device experiences a high drop on the observed damaged end.The occurrence rate of this failure was compared against the risk management documents and found to be within acceptable limits.Furthermore, a manufacturing record evaluation was performed for the finished device lot number, and no non-conformities were identified.The complaint information has been forwarded to the escalations team for their review.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 5.2 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: 8546329
• Report Number: 1221934-2019-56929
• Device Sequence Number: 400089
• Product Code: HRX
• UDI-Device Identifier: 10886705022489
• UDI-Public: (01)10886705022489
• 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
• Report Date (Section B): 04/01/2019

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 Expiration Date: 06/30/2023
• Device Model Number: 283346
• Device Catalogue Number: 283346
• Device Lot Number: A1807007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2019
• Initial Date Received by Manufacturer: 04/01/2019
• Supplement Date Received by Manufacturer: 06/28/2019
• Initial Report FDA Received Date: 04/24/2019
• Supplement Report FDA Received Date: 06/28/2019
• Patient Sequence Number: 1