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

Model Number	254514
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Udi: (b)(4) incomplete.The lot number is not currently available.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 surgical procedure, it was observed that a guidewire 1.1 mm x 15¿ device broke in the bone canal while screwing a milagro anchor device.It was reported that all of the broken pieces were removed from the patient.There was no delay in the surgical procedure.There was a spare device available for use to complete the surgery.There was patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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.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.Subsequent follow-up with the customer, additional information was received.It was reported that the patient's indication was cruciate ligament rupture, during the operation of acl reconstruction, insert the milagro into the lower bone canal, when screwing, the device was broken off in the bone canal.Removed all the broken pieces from the patient.There was a delay of 10 minutes.It was unknown if a spare device was available for use.
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.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.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.Given that no lot number was provided, a manufacturing record evaluation (mre) review cannot be performed.If the lot number becomes available, the mre review will be performed.Since the complaint device was discarded, we cannot determine a root cause for the reported failure.If additional information is received in the future, we will reopen the complaint and perform the investigation as appropriate.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).The lot number is unknown.

• 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: 9488548
• Report Number: 1221934-2019-60021
• Device Sequence Number: 1853885
• Product Code: FZX
• UDI-Device Identifier: 10886705013050
• UDI-Public: 10886705013050
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/02/2019

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 Model Number: 254514
• Device Catalogue Number: 254514
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/02/2019
• Supplement Date Received by Manufacturer: 12/24/2019; 01/23/2020
• Initial Report FDA Received Date: 12/18/2019
• Supplement Report FDA Received Date: 12/24/2019; 01/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 18 YR