MAUDE Adverse Event Report: DEPUY MITEK LLC US ARTHRO TISSLIB BLADE UP *EA; ORTHOPAEDIC KNIFE

Catalog Number	214623
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/31/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly.(b)(4).The complaint device is not being returned, therefore unavailable for a physical evaluation.A review into the depuy synthes mitek complaints system revealed no other complaints for this lot of devices that were released to distribution.We cannot discern a root cause for the reported failure mode.At this point in time, no corrective action is required and no further action is warranted.This file will remain receptive to any potential forthcoming information received that is pertinent and germane to this issue.A device history record review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.Our results indicate that this batch of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed.Dhr review: part number: 214623; supplier lot number: 08h3; qty of lot: 27; release to warehouse date: 24 devices supplied on the 31st of august 2008 and 3 supplied on 12th of october 2008; manufacturing date: august 2008; expiration date: na; supplier: tag; manufacturing site: tag; any anomalies or discrepancies in the manufacture of the lot: none.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.This report is being filed from the (b)(4) as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.(b)(4).
Event or Problem Description
It was reported that during a shoulder scope surgical procedure, it was observed that the handle on the tissue liberator separated from the shaft.The device broke stayed outside the patient and confirmed that no debris fell in the patient.The surgeon completed the procedure with another like device with no patient consequences or delays.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.

• Common Device Name: ORTHOPAEDIC KNIFE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8288663
• Report Number: 1221934-2019-56254
• Device Sequence Number: 2540734
• Product Code: NBH
• UDI-Device Identifier: 10886705004065
• UDI-Public: 10886705004065
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/01/2016

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: 214623
• Device Lot Number: 08H3
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/01/2016
• Initial Report FDA Received Date: 01/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1