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

Catalog Number	254643
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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 inspected.The complaint can be confirmed.The device was received broken in two pieces at the weld point where the handle meets the shaft.The laser lines of the device were heavily faded.The device is reusable, and no lot number is physically present on the device suggesting that it is at least 4 years old per the revision history of the drawing.This type of failure is typically observed after the device has been reprocessed over the course of many years therefore causing the weld integrity to degrade.However, given the information provided we cannot discern a definitive root cause for the reported failure.No lot numbers were supplied which precludes conducting a device history record (dhr) review.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).The lot number is unknown.
Event or Problem Description
It was reported by the sales rep via phone that during a knee arthroscopy with acl reconstruction procedure the customer's intrafix tibial sheath trial shaft broke while it was being malleted to dilate the tunnel.The sales rep stated that no fragments were created and the device was removed from the patient.There were no unusual procedural or anatomy factors that contributed to breakage.The customer's 7mm intrafix sheath inserter handle cracked from being malleted.The case was completed with another set of devices with no patient harm or delay.The sales rep could not provide lot numbers.The devices are being returned for evaluation.

• Common Device Name: SURGICAL SCREWDRIVER, REUSABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8483647
• Report Number: 1221934-2019-56762
• Device Sequence Number: 1723866
• Product Code: LXH
• UDI-Device Identifier: 10886705013357
• UDI-Public: 10886705013357
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 03/12/2019

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: Health Professional
• Device Catalogue Number: 254643
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/12/2019
• Initial Report FDA Received Date: 04/04/2019
• Patient Sequence Number: 1