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

Model Number	283345
Medical Device Problem Codes	Problem with Sterilization (1596); Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter is a mitek sales representative.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)(4) reports an event as follows: it was reported that the device packaging had a hole in one end and, therefore, could not be used because it was not sterile.This was found as the product was removed from the box of five (5) blades.No other products in the box were affected.The procedure was completed with a second device with no patient harm.This was spotted pre-operatively and it was a shoulder arthroscopy case.There was no delay to the case as another blade was used from the box.This report is for an omnicut 4.2 res blade.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, 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 in raynham site.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.At this point, no further action is warranted.

• 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: 8536485
• Report Number: 1221934-2019-56905
• Device Sequence Number: 19443919
• Product Code: HRX
• UDI-Device Identifier: 10886705022472
• UDI-Public: (01)10886705022472
• Combination Product (Y/N): N
• PMA/510(K) Number: K041824
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2019

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: No Information
• Device Expiration Date: 07/31/2023
• Device Model Number: 283345
• Device Catalogue Number: 283345
• Device Lot Number: A1808001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2019
• Supplement Date Received by Manufacturer: 08/12/2021
• Initial Report FDA Received Date: 04/22/2019
• Supplement Report FDA Received Date: 08/13/2021
• Patient Sequence Number: 1