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

Catalog Number	213710
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).Associated medwatch: [mr#1221934-2018-51697], [mr#1221934-2018-51698], [mr#1221934-2018-51700].
Event or Problem Description
It was reported by the sales rep that "soft tissue only" was etched into two of his rigidfix femoral rod 10mm and two of his rigidfix femoral rod 9mm when they are in fact btb devices.There was no case or patient involvement.The devices are being returned.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the complaint device was received and evaluated.Visually, the device seemed to be in good condition.As reported the device was not used, no procedure was involved.Upon further observation the correct etching was shown on the device.This complaint is not confirmed.Part number: 213710 has etching of ¿soft tissue only¿, which was confirmed on the drawing.This will be further reviewed under mitek pia.The dhr review indicated that this batch of devices was processed without incident therefore, there is no evidence of manufacturing anomalies on the records reviewed.Furthermore, a related complaint search in depuy synthes mitek complaints system revealed no complaints of any type for this lot of devices that was released to distribution.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).Associated medwatch: [mr#1221934-2018-51697][mr#1221934-2018-51698][mr#1221934-2018-51700].
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).Associated medwatch: [mr#1221934-2018-51697], [mr#1221934-2018-51698], [mr#1221934-2018-51700].

• Common Device Name: BONENAIL GUIDEWIRE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7596056
• Report Number: 1221934-2018-51699
• Device Sequence Number: 204943
• Product Code: FZX
• UDI-Device Identifier: 10886705003044
• UDI-Public: 10886705003044
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/31/2018

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: 213710
• Device Lot Number: 1704537
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2018
• Initial Date Received by Manufacturer: 10/01/2017
• Supplement Date Received by Manufacturer: 05/31/2018; 08/03/2018
• Initial Report FDA Received Date: 06/13/2018
• Supplement Report FDA Received Date: 06/26/2018; 08/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1