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	02/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional 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 sales rep reported via phone call that the customer's latarjet combo screwdriver failed during a laterjet procedure due to the tip of the driver breaking off when tightening a screw.The piece was found in the patient and all debris removed.The case was completed with another like device.The sales rep was not present but reported no adverse patient consequence and a 5 minute delay.The device will be returned for evaluation.
Event or Problem Description
The sales rep reported via phone that the tip of the driver broke off while tightening a screw on the customer's latarjet combo screwdriver during a laterjet procedure.The piece was found in the patient and all debris removed.The case was completed with another like device.The sales rep was not present but reported no adverse patient consequence and a 5 minute delay.The device will be returned for evaluation.
Additional Manufacturer Narrative
The complaint device was received and evaluated.Visual observation revealed that the distal tip was completely broken off, confirming this complaint.The broken fragment was not returned.The device was forwarded to the supplier for further evaluation.Dimensional analysis found that the device met specifications.The (b)(4) material for the device is 440c.The root cause for the observed failure mode was determined to be the brittle (b)(4) material, which makes the driver prone to break when being used at an angle off-axis to the screws.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 records reviewed.Review of the depuy synthes mitek complaints system revealed (b)(4) other similar complaint for this lot of devices released to distribution.Corrective actions for this failure mode will be implemented via supplier and mitek capa investigations.This product is being recalled after initial investigation of this failure.

• Brand Name: COMBO SCREWDRIVER
• Common Device Name: MITEK ARTHROSCOPIC INSTRUMENTS
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• MDR Report Key: 6379189
• Report Number: 1221934-2017-10093
• Device Sequence Number: 674169
• Product Code: LXH
• UDI-Device Identifier: 10886705026890
• UDI-Public: (01)10886705026890(10)16D02
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/02/2017
• Report Date (Section F): 02/10/2017

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2017
• Event Location: Hospital
• Date Report to Manufacturer: 02/10/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/10/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 03/04/2017
• Supplement Report FDA Received Date: 04/18/2017; 06/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1