MAUDE Adverse Event Report: DEPUY MITEK LLC US ABSOLUTE G-W NTNL 1.1MMX15 6PK; BONENAIL GUIDEWIRE

Catalog Number	254514
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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.(b)(6).Udi: (b)(4).
Event or Problem Description
It was reported by the affiliate via email that after screwing the absolute g-w ntnl 1.1mm x 15 6pk according to the procedure and checking the broach,when removing the guide broach, the distal end was broken at the first mark.During the ampli control, viewing of the broach fragment in the external femoral condyle.Decision to remain it in place.Implantation of a new broach and a new screw without any problem.Additional information received from the affiliate reported the device was purchased by the hospital.It was also reported it was decided that the fragment broach remain retained on the external femoral condyle and implant a new broach, which allowed for successful completion of the procedure.A surgical delay of a few minutes was reported and ansm deceleration was not required.The affiliate reported that is unknown if a new surgery will be required to remove the broken broach and the lot numbers of the broach and screws are unknown.It was reported that the device will not be returning for evaluation and the patient was discharged from the hospital but will require a consultation.
Additional Manufacturer Narrative
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.H10: additional narrative: h3, h6: investigation summary: the complaint device is not being returned.The broach fragment was implanted in the patient and the other part was not available to be returned, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.No nonconformances were identified for this part number, lot number 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.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.

• Brand Name: ABSOLUTE G-W NTNL 1.1MMX15 6PK
• Common Device Name: BONENAIL GUIDEWIRE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9167347
• Report Number: 1221934-2019-58843
• Device Sequence Number: 11358748
• Product Code: FZX
• UDI-Device Identifier: 10886705013050
• UDI-Public: 10886705013050
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2019

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: 03/31/2022
• Device Catalogue Number: 254514
• Device Lot Number: 4L35285
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/10/2019
• Supplement Date Received by Manufacturer: 10/29/2019
• Initial Report FDA Received Date: 10/08/2019
• Supplement Report FDA Received Date: 11/05/2019
• Patient Sequence Number: 1