MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM/130 DEG TI CANN TROCH FIXATION NAIL 340MM/LEFT-STER; ROD,FIXATION,INTRAMEDULLARY

Model Number	456.415S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional procode: hwc.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).Investigation summary: complaint summary: it was reported that on (b)(6) 2020, the patient underwent removal of titanium trochanteric fixation nail system (tfn) and cables due to painful hardware.The titanium cannulated trochanteric fixation nail (tfn) nail was removed successfully.A portion of the unknown cables remained in the patient.It is unknown if there was a surgical delay.There was no patient consequence reported.The instrument(s) was not returned and instead the investigation will be done based on the supplied image(s).The image(s) was reviewed and the complaint condition for painful hardware could not be confirmed based on the image provided.As the instrument(s) was not returned an as received condition, dimensional inspection, material or drawing reviews are not applicable.A definitive assignable root cause could not be determined based on the provided information.During the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history lot: manufacturing location: (b)(4).Manufacturing date: jul 17, 2015.Expiration date: june 30, 2024.Part number: 456.415s, 11mm/130 deg ti cann troch fixation nail 380mm/left ¿ sterile lot number: 9855750 (sterile).Work order traveler met all inspection acceptance criteria.Inspection sheet, in-process / inspect dimensional / final, ns054650 rev b met all inspection acceptance criteria.Packaging label log lppf, lmd/lpf rev k was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Scn 11571 supplied by ethicon (abq) was reviewed and determined to be conforming.This lot met all dimensional, visual, sterilization and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Component parts reviewed: component parts were not reviewed as the reported complaint condition of ¿removal due to painful hardware¿ does not indicate breakage of the nail or any of its components.Therefore, review of the raw materials would not be pertinent to the reported complaint condition.Device history review: aug 20, 2020: 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.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, the patient underwent removal of titanium trochanteric fixation nail system (tfn) and cables due to painful hardware.The titanium cannulated trochanteric fixation nail (tfn) nail was removed successfully.A portion of the unknown cables remained in the patient.It is unknown if there was a surgical delay.There was no patient consequence reported.This report is for one (1) 11mm/130 deg ti cann troch fixation nail 340mm/left-ster.This is report 1 of 5 for (b)(4).

• Brand Name: 11MM/130 DEG TI CANN TROCH FIXATION NAIL 340MM/LEFT-STER
• Common Device Name: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10511466
• Report Number: 2939274-2020-04059
• Device Sequence Number: 16902297
• Product Code: HSB
• UDI-Device Identifier: 10886982227812
• UDI-Public: (01)10886982227812
• 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 Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/12/2020

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 Expiration Date: 06/30/2024
• Device Model Number: 456.415S
• Device Catalogue Number: 456.415S
• Device Lot Number: 9855750
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/12/2020
• Initial Report FDA Received Date: 09/09/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 68