MAUDE Adverse Event Report: DEPUY MITEK LLC US SCR/WASH HEXDRV 2.5MM *EA; SURGICAL SCREWDRIVER, REUSABLE

Catalog Number	219124
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/03/2019
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 and not available for evaluation.No further information regarding the technique or instruments used has been provided to determine a root cause for this failure.Furthermore, no lot numbers were supplied which precludes conducting a batch history review or a lot specific search in the complaints handling system.Therefore, we cannot determine what caused the user to experience the reported event, we cannot discern a root cause for the reported failure mode.At this point in time, no corrective action is required, and no further action is warranted.However, should any new information be provided in future, this file will be re-opened, and a thorough investigation will be performed.Depuy 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 email and phone that during an anterior cruciate ligament reconstruction surgical procedure, it was observed that the customer's screw/washer driver tip broke while inserting a screw into the patient.The sales rep stated that the tip was removed from the patient with no debris left behind.The case was completed with another like-device with no patient harm or delay.The sales rep could not provide a lot number.The device was discarded by the customer.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.

• Common Device Name: SURGICAL SCREWDRIVER, REUSABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8219309
• Report Number: 1221934-2019-55924
• Device Sequence Number: 264735
• Product Code: LXH
• UDI-Device Identifier: 10886705005420
• UDI-Public: 10886705005420
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 01/03/2019

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: 219124
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/03/2019
• Initial Report FDA Received Date: 01/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1