MAUDE Adverse Event Report: DEPUY MITEK LLC US LATARJET GLENOID LONG DRILL BIT 3.2; SURGICAL HAND DRILL

Catalog Number	285300
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).The lot number is unknown.
Event or Problem Description
It was reported by the affiliate via cst that the cutting end of the latarjet glenoid long drill bit has snapped off.Broken piece not returned.Please see attached.This case has been reported by the loan kit technician during loan kit inspection.It has been forwarded to depuy engineering for assessment.No further information can be obtained as the case was not reported by the customer.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary = > the complaint device was received and evaluated.It was reported that the drill bit has snapped off.Pictures were provided, which shows evidence of a broken drill tip.This complaint is confirmed.The device age is approximately 6 years, possible root cause for the broken tip could be heavy use in the field.Another possible root cause for the broken tip could be due to the hard bone quality of the patient.This failure can be attributed to user technique and human factor however a specific root cause could not be determined.A manufacturing record evaluation was performed for the finished device product and lot number, and no non-conformances were identified.At this point in time, no corrective action is required, and 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.Udi: (b)(4).The lot number is unknown.

• Brand Name: LATARJET GLENOID LONG DRILL BIT 3.2
• Common Device Name: SURGICAL HAND DRILL
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8875984
• Report Number: 1221934-2019-57939
• Device Sequence Number: 11280379
• Product Code: LXH
• UDI-Device Identifier: 10886705018093
• UDI-Public: 10886705018093
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 07/14/2019

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: No Information
• Device Catalogue Number: 285300
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2019
• Initial Date Received by Manufacturer: 07/14/2019
• Supplement Date Received by Manufacturer: 08/27/2019
• Initial Report FDA Received Date: 08/08/2019
• Supplement Report FDA Received Date: 09/24/2019
• Patient Sequence Number: 1