MAUDE Adverse Event Report: DEPUY MITEK LLC US ACL ACC DISPOSABLES KIT *EA; ORTHOPAEDIC SURGICAL PROCEDURE KIT, NON-MEDICATED, SINGLE-USE

Catalog Number	232300
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	01/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.Hence, this complaint cannot be confirmed.No further information regarding the technique or instruments used has been provided to determine a root cause for this failure.If any additional information is obtained, this complaint will be re-opened to capture that information.Furthermore, a non-conformance search was conducted and no non-conformances were identified for this part number (232300), lot number (2l06521) combination.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.(b)(4).
Event or Problem Description
It was reported by the sales rep via phone that during an acl reconstruction procedure the sales rep's acl disposable kit guide wire tip broke off inside the patient.The sales rep stated that while inserting the screw approximately a four-five centimeter piece broke in the patient.The case was completed by removing the tip of the wire using a c-arm and a hemostat and following through with the remainder of the procedure.The sales rep stated all fragments were removed from the patient.There was no patient harm, but a twenty minute delay to remove the wire tip and finish the case.The device was discarded by the customer.

• Common Device Name: ORTHOPAEDIC SURGICAL PROCEDURE KIT, NON-MEDICATED, SINGLE-USE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8631511
• Report Number: 1221934-2019-57165
• Device Sequence Number: 19297304
• Product Code: LXH
• UDI-Device Identifier: 10886705011117
• UDI-Public: 10886705011117
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/07/2019

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 Expiration Date: 10/31/2023
• Device Catalogue Number: 232300
• Device Lot Number: 2L06521
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/07/2019
• Initial Report FDA Received Date: 05/22/2019
• Patient Sequence Number: 1