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

Catalog Number 232300

Device Problem Break (1069)

Patient Problems Foreign Body Reaction (1868); Foreign Body In Patient (2687)

Event Date 11/15/2017

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.¿ (b)(4) incomplete.The expiration date is not currently available.Associated medwatch: 1221934-2017-50069.

Event Description

About 6mm of ninal wire from an acl kit broke off while inserting milagro screw.Rep asked surgeon to remove wire prior to fulling setting screw however dr continued to advance screw and fully set it.At this time the wire could not be pulled out.This the screw had to be partly backed out then wire removed.Patient consequence? yes.Patient consequence description: 6mm of wire left in.Is the information being submitted for this complaint all the details that are known/available regarding this event? yes.

Manufacturer Narrative

Product complaint # (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, therefore is unavailable for a physical evaluation.A dhr review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.Our results indicate that nr was generated.This non-conformance is not relevant to the complaint condition since it concerns a packaging issue.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Therefore, we cannot determine what caused the user to experience the reported event, we cannot discern a root cause for the reported failure mode.A review into the mitek complaints system revealed no other complaint of any kind for this lot of devices.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).Associated medwatch:1221934-2017-50069.

Event Description

About 6 mm of ninal wire from an acl kit broke off while inserting milagro screw.Rep asked surgeon to remove wire prior to fulling setting screw however dr continued to advance screw and fully set it.At this time the wire could not be pulled out.This the screw had to be partly backed out then wire removed.Patient consequence?: yes.Patient consequence description: 6 mm of wire left in.Is the information being submitted for this complaint all the details that are known/available regarding this event?: yes.

• Brand Name: ACL DISPOSABLES KIT
• Type of Device: ORTHOPAEDIC SURGICAL PROCEDURE KIT, NON-MEDICATED, SINGLE-USE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jennifer lawrence ; 325 paramount drive; raynham, MA 02767 ; 5089776860
• MDR Report Key: 7120697
• MDR Text Key: 94948833
• Report Number: 1221934-2017-50068
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 232300
• Device Lot Number: L503546
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/15/2017
• Date Manufacturer Received: 05/22/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/30/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 16 YR