MAUDE Adverse Event Report: DEPUY MITEK LLC US RIGIDFIX FEM GDEFR B/T/B *EA; BONENAIL GUIDEWIRE

Model Number	213702
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).Udi: (b)(4).The lot number is unknown at this time.
Event or Problem Description
It was reported by affiliate via complaint submission tool the rigidfix fem gdefr b/t/b ea.The locking thumb screw has broken (the issue is the thumb screw, the rest of the instrument is in working order) the only thing requiring replacement is the thumb screw surgeon was using the device when he went to undo the thumb screw it broken.No harm or issue occurred to the patient as the jig was finished being used.No surgical delay.The device is not available to be returned for evaluation.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: investigation summary = > the complaint device is not being returned, the thumb screws of the device were discarded and the actual frame was retained by the customer, therefore unavailable for a physical evaluation.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.Further, no lot numbers were supplied which precludes conducting a dhr review or a lot specific search in the complaints handling system.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.

• Common Device Name: BONENAIL GUIDEWIRE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10445536
• Report Number: 1221934-2020-02292
• Device Sequence Number: 4092381
• Product Code: LXH
• UDI-Device Identifier: 10886705002962
• UDI-Public: 10886705002962
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Followup
• Report Date (Section B): 08/05/2020

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: 213702
• Device Catalogue Number: 213702
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/05/2020
• Supplement Date Received by Manufacturer: 09/17/2020
• Initial Report FDA Received Date: 08/24/2020
• Supplement Report FDA Received Date: 09/18/2020
• Patient Sequence Number: 1