MAUDE Adverse Event Report: DEPUY MITEK HEALIX TRANSTEND DRILL BIT; MITEK ARTHROSCOPIC INSTRUMENTS

Catalog Number	222281
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/03/2017
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 sales rep reported via phone call that the customer's healix transtend 2.2mm drill bit failed during a shoulder arthroscopy procedure due to the distal part of the tip breaking.The device broke in the per cannula system and not the patient.The case was completed using another like device.There were no adverse patient consequences or time delays.The device will be returned for evaluation.
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.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 complaint for this lot of devices that were released to distribution.This lot is 5 years old and irs a possibility that repeated use caused the tip to weaken and break.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.

• Brand Name: HEALIX TRANSTEND DRILL BIT
• Common Device Name: MITEK ARTHROSCOPIC INSTRUMENTS
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• MDR Report Key: 6379152
• Report Number: 1221934-2017-10085
• Device Sequence Number: 10996119
• Product Code: HTW
• UDI-Device Identifier: 10886705020331
• UDI-Public: (01)10886705020331(10)1208002
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2017
• Report Date (Section F): 02/03/2017

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: 222281
• Device Lot Number: 1208002
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Date Report to Manufacturer: 02/03/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/03/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/04/2017
• Supplement Report FDA Received Date: 04/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1