MAUDE Adverse Event Report: DEPUY MITEK LATARJET, GLENOID DRILL; MITEK ARTHROSCOPIC INSTRUMENT

Catalog Number	288241
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/16/2017
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 during a shoulder procedure, while drilling into the (glenoid) bone ,the peak of drill broke and was stock in the bone (glenoid).With quite some (tiring) trying, the surgeon was able to get the drill out again.The patient was not harmed.Additional information received via email from the affiliate on 4-13-17: the broken piece was about 10cm.The surgeon managed to pull the broken piece out of the bone and finished the surgery normally ¿ everything went well after that incident ¿ no harm on patient or other failure.The original bone hole was used to complete the procedure.No, they were no need to drill another whole.The complaint device is coming back for evaluation.
Additional Manufacturer Narrative
The complaint device was received and evaluated.Visual inspection revealed that the distal portion of the drill was broken, confirming this complaint.Closer visual inspection revealed a break at the laser weld which connects the drill tip to the shaft, which caused the entire drill tip including the portion contained within the shaft to become completely disengaged.The drill tip was measured and met length specification.Potential root causes for the observed failure include drilling at an angle which could cause the weld to fail or the patient having hard bone quality which could cause the drill to become stuck and break upon removal.However, a definitive root cause for this specific device failure cannot be determined.As an added visual observation, some slight corrosion of the laser markings was noted; a root cause cannot be conclusively determined.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 no other complaints of any type for this lot of devices released to distribution.At this time, no corrective action is required and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family to monitor the extent to which this complaint is observed in the field.

• Brand Name: LATARJET, GLENOID DRILL
• Common Device Name: MITEK ARTHROSCOPIC INSTRUMENT
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• MDR Report Key: 6491898
• Report Number: 1221934-2017-10160
• Device Sequence Number: 1122541
• Product Code: HTW
• UDI-Device Identifier: 10886705027316
• UDI-Public: (01)10886705027316(10)16E01
• 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): 03/16/2017
• Report Date (Section F): 03/16/2017

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: 288241
• Device Lot Number: 16E01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2017
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Report to Manufacturer: 03/16/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/16/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/13/2017
• Supplement Report FDA Received Date: 04/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1