MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10/130 DG TI CAN TROCH FIXATN NL 170-S; SCREW, FIXATION, BONE

Model Number	456.315S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	05/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #(b)(4).Additional pro-code: hsb.Investigation summary: background: it was reported that on an unknown date, during an orthopedic procedure, after the tfna implanted on (b)(6) 2021, the femur was broken below distal interlocking screw in nail.Nail, lag screw, and distal interlocking screw were removed on (b)(6) 2021 and swapped out with new tfna exchange nail, lag screw and new interlocking screw distally.The procedure successfully completed.Patient outcome is unknown.This complaint involves three (3) devices.Customer quality investigation: the device was not returned.A photo-investigation was performed on the images located in pc attachments ¿tfn nail 5.29.2021.Jpg", ¿img_7894.Jpg¿, ¿femur fracture 5.29.2021.Jpeg¿, and ¿lag screw 5.29.2021.Jpg¿.Upon inspecting the images provided, no issues were noted with the implant(s) that would contribute to the adverse event and therefore is unconfirmed.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.Conclusion: the complaint condition could not be confirmed during photo investigation.During the investigation, no product design issues, or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.Manufacturing location: (b)(4), manufacturing date: 19-feb-2021, expiration date: 31-jan-2030, part number: 456.315s, 10mm/130 deg ti cann troch fixation nail 170mm-sterile, lot number: 91p9486 (sterile), lot quantity: 6.Production order traveler met all inspection acceptance criteria.Inspection sheet, in-process/inspect dimensional/final ns072528 rev c met all inspection acceptance criteria.Packaging label log (pll) lppf rev m, lmd rev a was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Scn 19523 supplied by ethicon (abq) was reviewed and determined to be conforming.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.Component part(s) reviewed: part number: 456.314.3, lock driver tfn, lot number: 39p7149, lot quantity: 195.Production order traveler met all inspection acceptance criteria.Inspection sheet, inspect dimensional / final, 456fi314-3 rev h met all inspection acceptance criteria.Part number: 456.315.2, 130 degree lock prong tfn, lot number: 39p2990, lot quantity: 112.Production order traveler met all inspection acceptance criteria.Inspection sheet ns043681 rev j met all inspection acceptance criteria.Part number: 21069, tialnbri18.00, lot number: h172232, lot quantity: 2,952 lbs.Certificate of tests supplied by ati specialty materials dated 12-jul-2016 was reviewed and determined to be conforming.Lot summary report dated 17-aug-2016 net all inspection acceptance criteria.Raw material receiving/putaway checklist met all inspection acceptance criteria.Device history batch: null.Device history review: 09-jun-2021: dhr reviewed by: mschoenfeld 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.
Event or Problem Description
It was reported that on an unknown date, during an orthopedic procedure, after the tfna implanted on (b)(6) 2021, the femur was broken below distal interlocking screw in nail.Nail, lag screw, and distal interlocking screw were removed on (b)(6) 2021 and swapped out with new tfna exchange nail, lag screw and new interlocking screw distally.The procedure successfully completed.Patient outcome is unknown.This complaint involves three (3) devices.This report is for one (1) 10/130 dg ti can troch fixatn nl 170-s this report is 1 of 3 for (b)(4).

• Brand Name: 10/130 DG TI CAN TROCH FIXATN NL 170-S
• 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: 12060553
• Report Number: 2939274-2021-03195
• Device Sequence Number: 14503873
• Product Code: HWC
• UDI-Device Identifier: 10886982226907
• UDI-Public: (01)10886982226907
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K011857
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 456.315S
• Device Catalogue Number: 456.315S
• Device Lot Number: 91P9486
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/29/2021
• Initial Report FDA Received Date: 06/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Weight: 82