MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 26MM FOR IM NAILS; SCREW, FIXATION, BONE

Model Number	04.005.516
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information is unknown.This report is for a screw - unknown lot.Device remained in the patient.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.
Event or Problem Description
It was reported that during an ankle arthrodesis procedure on (b)(6) 2018, as the surgeon attempted to insert two (2) locking screws into the nail, there was a misalignment issue.The drill bit would not align with the nail.Surgeon decided to use perfect circle technique.The same drill bit was used to insert two (2) locking screws and the procedure was completed successfully.Post-operative radiographs were used to confirm the same.There was no surgical delay and the patient is reported to be in stable condition.It was reported that the aiming arm and guide wire worked fine when used in prior surgeries.Concomitant devices reported: 10 mm ti hindfoot arthrodesis cannulated nail (part# 04.008.066s, lot# 7423633, quantity 1).This complaint is for three (3) devices.(b)(4).This report is for a screw.

• Brand Name: 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 26MM FOR IM NAILS
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7344962
• Report Number: 2939274-2018-51089
• Device Sequence Number: 16579523
• Product Code: HWC
• UDI-Device Identifier: 10886982085849
• UDI-Public: (01)10886982085849(10)LOTUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K172157
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 02/15/2018

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 Model Number: 04.005.516
• Device Catalogue Number: 04.005.516
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/15/2018
• Initial Report FDA Received Date: 03/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR