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

Catalog Number	214622
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/20/2015
Type of Reportable Event	Malfunction
Additional Manufacturer 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 complaint device was received and evaluated.Visual observation confirms the device is broken into two pieces, separated at the shaft-handle interface.The device appears extremely worn; the color of the handle is faded and the laser etch on the shaft is considerably faded, indicating the device is old and heavily used.This failure is typical of excessive abuse of the device and therefore can be attributed to field wear.A review of the device history record indicated that this batch of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed.Further, a review into the mitek complaints system revealed no other complaints from this lot of devices that were released for distribution in 2007.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.This report is being filed from (b)(4) as required under mitek¿s corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
Event or Problem Description
The sales representative reported that the customer¿s tissue liberator atraumatic-down broke in half during the procedure; it was noted the device was not in the patient at the time.The surgeon completed the procedure with another like device, with no delay and no patient consequences.

• Common Device Name: ORTHOPAEDIC KNIFE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8102573
• Report Number: 1221934-2018-53940
• Device Sequence Number: 2017895
• Product Code: NBH
• UDI-Device Identifier: 10886705004058
• UDI-Public: 10886705004058
• 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): 05/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 214622
• Device Lot Number: 7D4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2015
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/20/2015
• Initial Report FDA Received Date: 11/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1