MAUDE Adverse Event Report: DEPUY MITEK LLC US RIGIDFIX FEMROD B/T/B 11MM *EA; BONENAIL GUIDEWIRE

Catalog Number	213711
Medical Device Problem Code	Misassembled During Installation (4049)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/12/2018
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).The lot number is not currently available.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Investigation summary: the complaint device is not being returned, therefore unavailable for a physical evaluation.However, from the photo available the complaint rigidfix rod was having issue sliding into and out of the rigidfix btb guide frame cannot be confirmed.The potential cause for this issue is not related to manufacturing, therefore a manufacturing record evaluation is not required.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.This report is being filed as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
Event or Problem Description
It was reported by the affiliate in new (b)(6) that during an acl repair surgical procedure, it was observed that the 11mm rigidfix rod was having issue sliding into and out of the rigidfix btb guide frame.All the other sizes were fitting okay.Replacements were requested but when they were received they also did not fit, so a loan kit was sent to bridge the gap.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.

• Common Device Name: BONENAIL GUIDEWIRE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9123720
• Report Number: 1221934-2019-58566
• Device Sequence Number: 16727766
• Product Code: FZX
• UDI-Device Identifier: 10886705003051
• UDI-Public: 10886705003051
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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
• Type of Report: Initial
• Report Date (Section B): 10/12/2018

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 Catalogue Number: 213711
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/12/2018
• Initial Report FDA Received Date: 09/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1