MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10/130 DEG TI CANN TFNA 340/LEFT - SILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	04.037.055S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	09/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 history lot: manufacturing location: (b)(4).Manufacturing date: 28-jun-2021.Expiration date: 31-may-2031.Part number: 04.037.055s, 10mm/130 deg ti cann tfna 340mm/left ¿ sterile.Lot number: 231p190 (sterile).Production order traveler met all inspection acceptance criteria.Inspection sheet, in-process / inspect dimensional / final, nonconformance review met all inspection acceptance criteria.Inspection sheet, tfna assembly inspection, nonconformance review met all inspection acceptance criteria.Packaging label log (pll) was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Scn 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 part(s) reviewed: component parts were not reviewed as the reported complaint condition of ¿surgeon perforated the femoral neck with the helical blade¿ 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: 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) 2021, during an unknown procedure, while inserting a tfna nail, the surgeon perforated the femoral neck with the helical blade.The nail and helical blade were extracted, and reinserted.The helical blade was repositioned in the femoral neck and the surgery was completed successfully.During extraction, one of the prongs of the connection interface was slightly bent; however the nail was successfully reconnected and inserted.There was a (15) minute surgical delay.The procedure was successfully completed with no patient consequences.This report is for (1) 10/130 deg ti cann tfna 340/left - sile.This is report 2 of 2 for (b)(4).

• Brand Name: 10/130 DEG TI CANN TFNA 340/LEFT - SILE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12639940
• Report Number: 2939274-2021-06126
• Device Sequence Number: 3413480
• Product Code: HSB
• UDI-Device Identifier: 10886982096111
• UDI-Public: 10886982096111
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/17/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.037.055S
• Device Catalogue Number: 04.037.055S
• Device Lot Number: 231P190
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/17/2021
• Initial Report FDA Received Date: 10/15/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RIA 2 BONE HARVESTING KIT 520MM STERILE; TFNA FENESTRATED HELICAL BLADE 75 - SILE
• Patient Age: 48 YR
• Patient Weight: 68