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

Model Number	232300
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Occupation: synthes rep.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.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.
Event or Problem Description
Device report from synthes depuy mitek reports an event in (b)(6) as follows: it was reported by the sales rep via phone the during an acl procedure about a 1 cm portion of the nitinol guidewire of the customer's acl disposable kit broke off in the patient while implanting a screw.The sales rep stated that the broken piece is lodged in the patient's femoral bone and that the surgeon made the decision to leave it in the patient.The procedure was at the end and been completed with the device before the issue occurred with no surgical delay the case.The sales rep stated that the other portion of the broken nitinol wire was discarded by the customer.This report is for one (1) acl acc disposables kit *ea.This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: udi: (b)(4).Investigation summary: the complaint device is not being returned, one part of the product was implanted in the patient and the remaining part was discarded by the customer, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.The sales rep stated that the patient had hard bone which might have caused difficulty for the screw to advance resulting in breakage, therefore is a possible root cause of the reported issue.However without the return of the complaint device, and no further information provided we cannot determine a definitive root cause.No nonconformances were identified for this part-lot number combination per qlik query executed 08/26/2019.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.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.
Event or Problem Description
Further it was reported that patient had hard bone.

• 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: 8893301
• Report Number: 1221934-2019-57985
• Device Sequence Number: 1617712
• Product Code: LXH
• UDI-Device Identifier: 10886705011117
• UDI-Public: (01)10886705011117
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2019

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: 10/31/2023
• Device Model Number: 232300
• Device Catalogue Number: 232300
• Device Lot Number: 2L06522
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/17/2019
• Supplement Date Received by Manufacturer: 08/27/2019
• Initial Report FDA Received Date: 08/14/2019
• Supplement Report FDA Received Date: 09/05/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention