MAUDE Adverse Event Report: DEPUY MITEK LLC US TRACKER DRBIT 2.0X6.5" *EA; BONENAIL GUIDEWIRE

Catalog Number	219460
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.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
It was reported by the sales rep via phone that during a unknown procedure the sales rep's 2mm tracker drill bit was being drilled into the bone and the tip broke.The sales rep stated that all pieces were removed from the patient using a grasper and that they verified all pieces were removed using a mini x-ray.The sales rep stated that the patient's bone quality was hard.The case was completed with another like-device with the same bone hole with no patient harm or delays.There was patient involvement reported.There were no 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.
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.Additional narrative: 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.The complaint can be confirmed.Visual observation revealed that the device is broken in two pieces at the distal tip, and the surface is covered with debris.According to the event description the patient's bone quality was hard.Therefore, it is possible that the drill hit the patient's hard bone which caused torsional friction on the drill bit tip causing it to break.However, given the information provided we cannot discern a definitive root cause for the reported failure.A device history record (dhr) review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.Our results indicate that this batch of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed.At this point, 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.Udi: (b)(4).

• Common Device Name: BONENAIL GUIDEWIRE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7947157
• Report Number: 1221934-2018-54876
• Device Sequence Number: 941133
• Product Code: HTW
• UDI-Device Identifier: 10886705006618
• UDI-Public: 10886705006618
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Followup
• Report Date (Section B): 09/27/2018

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: 219460
• Device Lot Number: 1705001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2018
• Initial Date Received by Manufacturer: 09/27/2018
• Supplement Date Received by Manufacturer: 02/07/2019
• Initial Report FDA Received Date: 10/09/2018
• Supplement Report FDA Received Date: 02/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1