MAUDE Adverse Event Report: DEPUY MITEK LLC US LATARJET CANN. SCREWDRIVER; SURGICAL SCREWDRIVER, REUSABLE

Catalog Number	285220
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/05/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi: (b)(4).The complaint devices were received and evaluated.Visual observation confirms that the distal tips of both devices were rounded.The devices are worn and laser markings have faded indicating it was heavily used.This complaint can be confirmed.A batch review request to the supplier determined that this device is more than 2 years old and a batch review could not be performed.Further, a review into the depuy mitek complaints system revealed 3 similar complaints for this lot.This device is 5 years old and due to heavy use, their failure could be attributed to normal field wear.At this point in time, no corrective action is required and no further action is warranted.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 however, depuy 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 etq complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
Event or Problem Description
This is report 1 of 2 for the same event.It was reported by the sales rep that during an unspecified surgical procedure of the shoulder, it was observed that two of the latarjet cannula screw drivers are stripped and broken.The sales rep confirmed that nothing broke in the patient.The sales rep reported that the surgeon completed the procedure with another different type of driver with no patient consequences or delays.The sales rep could not provide lot numbers for the devices.The sales rep was not present for the case therefore could not provide any further information.The devices will be returning for evaluation.

• Brand Name: LATARJET CANN. SCREWDRIVER
• Common Device Name: SURGICAL SCREWDRIVER, REUSABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8254338
• Report Number: 1221934-2018-51855
• Device Sequence Number: 11301393
• Product Code: LXH
• UDI-Device Identifier: 10886705017904
• UDI-Public: 10886705017904
• 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): 07/05/2016

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: 285220
• Device Lot Number: 10D2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2016
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/05/2016
• Initial Report FDA Received Date: 01/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1