MAUDE Adverse Event Report: DEPUY MITEK LLC US RIGIDFIX FEMROD 10MM *EA; BONENAIL GUIDEWIRE

Model Number	213710
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation summary: according to the information provided, it was reported that after an acl procedure the rigidfix femoral btb guide frame n/s 1pk and the rigidfix femoral rod 10 mm 1pk got stuck together.It looks like the screw broke up and got stuck in the guide.The complaint device was received and evaluated.Visual observations revealed that the device was worn.Also, it was found with scratches, and the laser marks was slightly faded.The rigidfix femoral btb guide frame n/s 1pk ,and the rigidfix femoral rod 10 mm 1pk g from the shaft connection point revealed that the device had been heavily used due to the metal surface had striations, and it appeared to lose the metal.It was difficult to assembled the both devices.As a result, it was jammed.This complaint can be confirmed.The possible route cause could be related to the use and servicing, this failure can be attributed to the field wear.For the damage in the metal can be attribute when the device might have been tapped against a hard surface on several occasions and will generate wear in the metal.Therefore, it can generate difficult to assemble because of the damage observed.However, it cannot be conclusively affirmed.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.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.
Event or Problem Description
It was reported by the sales rep via phone that after an acl procedure the rigidfix femoral btb guide frame n/s 1pk and the rigidfix femoral rod 10 mm 1pk got stuck together.It looks like the screw broke up, and got stuck in the guide.No patient consequences or procedure delay reported as the case was already completed.These devices are available to be returned for evaluation.

• Common Device Name: BONENAIL GUIDEWIRE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10536759
• Report Number: 1221934-2020-02627
• Device Sequence Number: 3830645
• Product Code: FZX
• UDI-Device Identifier: 10886705003044
• UDI-Public: 10886705003044
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/31/2020

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: 213710
• Device Catalogue Number: 213710
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/31/2020
• Initial Report FDA Received Date: 09/15/2020
• Patient Sequence Number: 1