MAUDE Adverse Event Report: DEPUY MITEK COMBO SCREWDRIVER; MITEK ARTHROSCOPIC INSTRUMENTS

Catalog Number	288211
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/15/2017
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.
Event or Problem Description
The affiliate reported via email the screwdriver is broken off at the tip.However, the tip could be removed intraoperatively.The procedure was completed with same like product with a five minute delay.Additional information received via email from the affiliate on 3-17-2017.The tip of the screwdriver did fall into the patient.
Additional Manufacturer Narrative
The complaint device is not available for a physical evaluation.No further information regarding the technique or instruments used has been provided to determine a root cause for this failure.This failure is being investigated under supplier capa-(b)(4) and mitek capa-(b)(4).The root cause has been attributed to the material selection combined with off axis use.These drivers are made of 440c stainless steel which has a low fracture toughness, making it more susceptible to fractures and breaking.This product is being recalled after initial investigation of this failure (b)(4).Reference internal recall number 1221934-05-10-17-001-r.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 lot was released in two batches on jun 16, 2016 and aug 11, 2016.

• Brand Name: COMBO SCREWDRIVER
• Common Device Name: MITEK ARTHROSCOPIC INSTRUMENTS
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• MDR Report Key: 6491698
• Report Number: 1221934-2017-10157
• Device Sequence Number: 19243179
• Product Code: LXH
• UDI-Device Identifier: 10886705026890
• UDI-Public: (01)10886705026890(10)16D02
• Combination Product (Y/N): N
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2017
• Report Date (Section F): 03/15/2017

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: 288211
• Device Lot Number: 16D02
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Report to Manufacturer: 03/15/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/15/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/13/2017
• Supplement Report FDA Received Date: 06/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1