MAUDE Adverse Event Report: DEPUY MITEK 30MM MODULAR DRIVER - BIOCOMPOSITE; MITEK ARTHROSCOPIC INSTRUMENTS

Catalog Number	219958
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/06/2017
Type of Reportable Event	Malfunction
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.A dhr review has been conducted and the results indicate that this batch of product was processed without any incident and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy mitek complaints system revealed one similar complaints for this lot of devices that were released to distribution.At this point in time, no further action is warranted.However, should any new information be provided in future, this file will be re-opened and a thorough investigation will be performed.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.
Event or Problem Description
The affiliate reported via email the device broke at the final tightening of the screw.Additional information received via email from the affiliate on (b)(6) 2017 there was no harm to the patient, he did not need to be hospitalized, he did not need another surgical procedure, he did not have any other serious damage and the metal part of the broken key was removed without intercurrences.The piece broke and stayed inside the screw, the surgeon was able to remove the piece with a strong tweezers.

• Brand Name: 30MM MODULAR DRIVER - BIOCOMPOSITE
• Common Device Name: MITEK ARTHROSCOPIC INSTRUMENTS
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• MDR Report Key: 6473468
• Report Number: 1221934-2017-10138
• Device Sequence Number: 371220
• Product Code: LXH
• UDI-Device Identifier: 10886705007011
• UDI-Public: (01)10886705007011(10)1405001
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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
• Report Date (Section B): 03/09/2017
• Report Date (Section F): 03/09/2017

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: 219958
• Device Lot Number: 1405001
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Report to Manufacturer: 03/09/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2017
• Initial Report FDA Received Date: 04/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1