MAUDE Adverse Event Report: DEPUY MITEK MITEK LUPINE FISHMOUTH DRILL GUIDE; SURGICAL HAND DRILL GUIDE

Catalog Number 213817

Device Problem Metal Shedding Debris (1804)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/28/2016

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).Device not yet received.

Event Description

The sales rep reported via phone that the tip of the customers lupine stabilization fish mouth drill guide bent during a shoulder arthroscopy and there were metal shaving in the patient.All the metal shavings were removed and the case was completed with another like instrument.There were no patient consequences or delays.The sales rep stated that the device will be returned.

Manufacturer Narrative

The complaint device has not been returned for physical evaluation after multiple follow ups.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 no other 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.

• Brand Name: MITEK LUPINE FISHMOUTH DRILL GUIDE
• Type of Device: SURGICAL HAND DRILL GUIDE
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jennifer lawrence ; 325 paramount drive; raynham, MA 02767 ; 5089776860
• MDR Report Key: 6206473
• MDR Text Key: 63330760
• Report Number: 1221934-2016-10567
• Device Sequence Number: 1
• Product Code: FZX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/28/2016,12/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 213817
• Device Lot Number: 4K1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: 12 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/28/2016
• Date Manufacturer Received: 03/23/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/11/2004
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1