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

Model Number	04.005.516S
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Manufacturing location: (b)(4), manufacturing date: june 19, 2019, expiration date: april 30, 2028, part number: 04.005.516s, 5.0mm ti locking screw w/t25 stardrive 26mm f/im nail-sterile, lot number: 3l20002 (sterile), lot quantity: 122.This lot was reworked for discoloration in the stardrive.Entire lot was determined to be acceptable after rework.Production order traveler met all inspection acceptance criteria.Inspection sheet, whirl threads, vibe, flute / final inspection met all inspection acceptance criteria after rework.Packaging label log (pll) lppf rev e, lmd was reviewed and was determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Component(s) reviewed: component parts were not reviewed because the reported complaint condition of ¿aiming arm almost impossible to remove causing the screw used to be too short¿ does not indicate failure or breakage of the screw.Therefore, review of the raw materials would not be pertinent to the reported complaint condition.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.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.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 on (b)(6) 2020 during the insertion of a tibia nail and proximal interlock there was difficulty screwing the aiming arm for suprapatellar unto the insertion handle for suprapatellar.The aiming arm felt stripped.The aiming arm was eventually screwed on and was used in the procedure.Removal of the aiming arm was almost impossible, which caused the surgeon to measure the ti locking screw through the aiming arm.The locking screw measured too short and could not be used.Another longer, unknown screw was used instead.It is unknown if there was a surgical delay.Procedure outcome and patient status are unknown.Concomitant devices reported: insertion handle for suprapatellar (part number 03.010.440, lot 170472-101, quantity 1), aiming arm for suprapatellar (part number 03.010.441, lot 170387, quantity 1).This report involves one (1) 5.0mm ti locking screw w/t25 stardrive 26mm f/im nail-ster.This is report 1 of 3 for (b)(4).

• Brand Name: 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 26MM F/IM NAIL-STER
• 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: 10100720
• Report Number: 2939274-2020-02556
• Device Sequence Number: 17034329
• Product Code: HWC
• UDI-Device Identifier: 10886982085856
• UDI-Public: (01)10886982085856
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K172157
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/18/2020

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: 04.005.516S
• Device Catalogue Number: 04.005.516S
• Device Lot Number: 3L20002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/18/2020
• Initial Report FDA Received Date: 05/29/2020
• Patient Sequence Number: 1
• Patient Age: 47 YR