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	Foreign Body In Patient (2687)
Date of Event	01/07/2019
Type of Reportable Event	Serious Injury
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 (l746310) 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 following an acl reconstruction procedure during the post-opt x-ray, it was noticed that the sales rep's acl disposable kit guide wire tip broke off in the patient during the case.The sales rep stated that there is approximately a 15mm piece of the guide wire in the patient's femur.The case was completed with this kit with no time delay.The sales rep stated there is no plan for surgical intervention.The guide wire tip remains in the patient, while the remainder of the acl disposable kit 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: 8301187
• Report Number: 1221934-2019-56309
• Device Sequence Number: 985834
• Product Code: LXH
• UDI-Device Identifier: 10886705011117
• UDI-Public: 10886705011117
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 232300
• Device Lot Number: L746310
• 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: 02/04/2019
• Patient Sequence Number: 1