MAUDE Adverse Event Report: DEPUY MITEK LLC US LOW PROFILE REAMER, 10MM; CANNULATED SURGICAL DRILL

Catalog Number	219632
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi: (b)(4)-incomplete.The lot number is currently unavailable.Investigation summary: the complaint device was discarded by the customer.Therefore, the device is not available for a physical evaluation.This complaint is not confirmed.Without physically evaluating the device, a definite root cause cannot be determined.Furthermore, no lot number was 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.This file will remain receptive to any potential forthcoming information received that is pertinent and germane to this issue.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.
Event or Problem Description
It was reported by the sales rep via phone the customer's 10mm low profile reamer tip broke off.The sales rep did not know when this occurred, but believed it happened during sterilization.The sales rep stated no case was involved, therefore there was no patient involvement or delay.The sales rep could not provide any additional information.The sales rep could not provide a lot number.The device was discarded by the customer.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: LOW PROFILE REAMER, 10MM
• Common Device Name: CANNULATED SURGICAL DRILL
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8128667
• Report Number: 1221934-2018-55516
• Device Sequence Number: 13492522
• Product Code: HTO
• UDI-Device Identifier: 10886705024292
• UDI-Public: 10886705024292
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/26/2018

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: 219632
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/26/2018
• Initial Report FDA Received Date: 12/04/2018
• Patient Sequence Number: 1