MAUDE Adverse Event Report: DEPUY MITEK LLC US ACL ACC G-W NTNL 9X.042" *PK/6; BONENAIL GUIDEWIRE

Catalog Number	254417
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4)-incomplete.The lot number is currently unavailable; therefore, the manufacture date is 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
It was reported by the affiliate in (b)(6) that during an anterior cruciate ligament (acl) reconstruction procedure, it was observed that the guide wire broke when inserting the milagro screw in the tibial channel.According to the report, there was an approximately 3 cm missing when removing the guide wire.It was reported that the 3 cm part could not be found.It was reported that the surgery was completed but x-ray was planned the next week.It was reported that the surgeon was now using the guide wire.It was not reported if there were any delays in a surgical procedure or if a spare device was available.There was patient involvement.There were no reports of prolonged hospitalization.The patient's status post-surgery was not provided.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
Event or Problem Description
Additional information received from affiliate on 26october2018: it was reported the device will be available to return to the manufacturer for investigation.
Additional 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.Udi: (b)(4).The lot number is not currently available.
Additional 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 was received and evaluated.Visual observation confirms approximately 3 cms of the distal tip is broken, as reported.This complaint is confirmed.Additionally, the guide wire was slightly bent.Possible root cause for these type of failures could be that the user applied excessive force while using the device or hitting another instrument during use, however a specific root cause could not be determined.Furthermore, no lot numbers were supplied which precludes conducting a dhr review or a lot specific search in the complaints handling system.At this 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 to monitor the extent to which this complaint is observed in the field.Udi: (b)(4).

• Common Device Name: BONENAIL GUIDEWIRE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7938269
• Report Number: 1221934-2018-54826
• Device Sequence Number: 19332507
• Product Code: FZX
• UDI-Device Identifier: 10886705012916
• UDI-Public: 10886705012916
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/05/2018

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 Catalogue Number: 254417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2018
• Initial Date Received by Manufacturer: 09/05/2018
• Supplement Date Received by Manufacturer: 10/26/2018; 11/29/2018
• Initial Report FDA Received Date: 10/05/2018
• Supplement Report FDA Received Date: 10/29/2018; 12/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1