MAUDE Adverse Event Report: DEPUY MITEK LLC US INTRAFIX TIBSHEATH TRIAL/T-HDLE *EA; SURGICAL SCREWDRIVER, REUSABLE

Model Number	254643
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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 is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.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.Udi: (b)(4).The lot number is unknown.
Event or Problem Description
It was reported by the sales rep via phone that during an acl procedure the biointrafix tibial sheath trial, 9mm with t-handle broke when the surgeon was making the pilot hole for the implant.No patient consequences or surgical delay reported.The device was discarded.Additional information received from the affiliate reported the case was completed with another set of in-house instruments.The affiliate also reported the lot number of the device is not available because the device was discarded.It was reported the handle broke at the base of the "t" during impaction and no surgical intervention needed or planned.

• Common Device Name: SURGICAL SCREWDRIVER, REUSABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9983547
• Report Number: 1221934-2020-01220
• Device Sequence Number: 4442883
• Product Code: LXH
• UDI-Device Identifier: 10886705013357
• UDI-Public: 10886705013357
• 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,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/03/2020

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 Model Number: 254643
• Device Catalogue Number: 254643
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/03/2020
• Initial Report FDA Received Date: 04/21/2020
• Patient Sequence Number: 1