MAUDE Adverse Event Report: DEPUY MITEK LLC US DRILL BIT SUPER/RC/GLS 2.9 MM; SURGICAL HAND DRILL

Model Number	211113
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Complainant part is not expected to be returned for manufacturer review / investigation, it was discarded.Occupation: synthes mitek rep.Without a lot number, the device history records review could not be completed as no product was received.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.Udi: (b)(4), incomplete.
Event or Problem Description
It was reported by the sales rep via phone that the tip of the customer's super / rc drill bit 2.9 mm broke off while drilling a bone hole in a rotator cuff repair procedure.All pieces of the broken drill bit were removed from the patient.The surgeon used another like device to complete the procedure with a three to five minute delay and no patient consequence.The customer reported to the sales rep that they may have been a little off axis while drilling into a little hard bone.The device was discarded by the customer.This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
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.H3 (device evaluated by mfr), h6: investigation summary the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.The customer reported to the sales rep that they may have been a little off axis while drilling into a little hard bone, therefore is a possible root cause of the reported problem.However without the return of the complaint device, and no further information provided we cannot determine a definitive root cause.Further, no lot numbers were supplied which precludes conducting a dhr review or a lot specific search in the complaints handling system.At this point in 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 as a means of monitoring the extent with which this complaint is observed in the field.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.

• Brand Name: DRILL BIT SUPER/RC/GLS 2.9 MM
• Common Device Name: SURGICAL HAND DRILL
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9084771
• Report Number: 1221934-2019-58403
• Device Sequence Number: 2664600
• Product Code: HTW
• UDI-Device Identifier: 10886705001583
• UDI-Public: (01)10886705001583
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2019

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 Model Number: 211113
• Device Catalogue Number: 211113
• Initial Date Received by Manufacturer: 08/21/2019
• Supplement Date Received by Manufacturer: 09/26/2019
• Initial Report FDA Received Date: 09/18/2019
• Supplement Report FDA Received Date: 10/15/2019
• Patient Sequence Number: 1