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 Codes	Tissue Damage (2104); Foreign Body In Patient (2687)
Date of Event	04/03/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4)- incomplete.The exp date is currently unavailable.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.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
This is report 2 of 2 for the same event.It was reported by the sales rep that during an acl procedure the 2.4mmx18 beath pin in the customer's acl disposable kit broke in half when the surgeon was trying to drill thru the femur.The broken piece was removed with a pair of pliers with no issues.The sales rep stated that the patient was overweight and the surgeon had to use excessive force in small spaces to create larger tunnels.The procedure was completed with a competitor's product with no harm to the patient or delays to the case.Post to the procedure the sales rep was made aware on april 19th that the 1.1mmx15 nitinol guidewire from the kit also had broken in the patient during the same case but was found after the procedure.The piece of guidewire was removed from the patient in a separate case with no issues.Unknown what date the guidewire was removed from the patient.The sales rep confirmed that the patient's current condition is fine.The sales rep stated that both devices were discarded by the customer.It was clarified that two parts of the acl disposable kit broke during the case.The surgeon reported that the patient has extremely hard bone undergoing an acl repair.The surgeon also confirmed that a beath pin was used for access and broke at the initial surgery.This was noted at the time and removed.For the insertion of a 8x23mm milagro screw, a guidewire was next utilized.The surgery fixation was completed and the patient was closed.During post-surgery x-rays, dr.Noted a remaining piece of the guidewire embedded in the lateral distal soft tissue of the femoral.It was determined that this non-implantable guidewire piece should be removed.A re-surgery was scheduled approximately 1.5 weeks post initial surgery.The second surgery was uneventful and did not delay the recovery or pt of the patient.All available information has been disclosed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Date received by manufacturer should be december 14, 2018.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.
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the 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.This complaint cannot be confirmed.  a non-conformance search was performed for this product code 232300-lot #l553178 combination and no non-conformance were identified.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.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.Udi: (b)(4).

• 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: 7978343
• Report Number: 1221934-2018-54995
• Device Sequence Number: 19227225
• Product Code: LXH
• UDI-Device Identifier: 10886705011117
• UDI-Public: 10886705011117
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,Followup,Followup
• Report Date (Section B): 04/03/2018

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: 09/30/2022
• Device Catalogue Number: 232300
• Device Lot Number: L553178
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/03/2018
• Supplement Date Received by Manufacturer: 04/03/2018; 10/25/2019
• Initial Report FDA Received Date: 10/18/2018
• Supplement Report FDA Received Date: 12/17/2018; 10/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Age: 35 YR