MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12MM/130 DEG TI CANN TFNA 380MM/LEFT-STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	04.037.259S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Health effect clinical code e2402 is reported to capture reported event of bone injury.A device history record (dhr) review was conducted: manufacturing location: monument, manufacturing date: 21-feb-2020, expiration date: 31-jan-2030, part number: 04.037.259s, 12mm/130 deg ti cann tfna 380mm/left- sterile, lot number: 41p7959 (sterile), lot quantity: 4.One piece was scrapped, inspect dimensional/laser, for an illegible etch.One piece was scrapped in cell, bead blast, for surface finish dings / scratches.Production order traveler met all inspection acceptance criteria apart from the two pieces noted.Inspection sheet, in-process / inspect dimensional / final, met all inspection acceptance criteria apart from the one piece (laser etch) noted.Inspection sheet, tfna assembly inspection, met all inspection acceptance criteria.Packaging label log (pll) lppf was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Scn 17342 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: component parts were not reviewed as the reported complaint condition of ¿guide wire missed blade hole of nail; user error¿ 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.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.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 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) 2019, during a trochanteric fixation nail advanced (tfna) case, while putting in the guide wire into the neck and head of the femur, surgeon missed the blade hole in the nail.Surgeon drilled for the blade into the head and inserted the blade.When lateral x-rays was taken then it was noticed that nail was missed and the blade was not through it.Surgeon was able to remove the blade from the head and the nail from the femur without incident.Surgeon then inserted a new nail and inserted another guide wire through the nail and ultimately implanted the helical blade through the hole and into the head.There was no surgical delay reported.The procedure was successfully completed.Concomitant device reported: guide wire (part# unknown; lot# unknown; quantity: 1), helical blade (part# unknown; lot# unknown; quantity: 1).This report is for 1 12mm/130 deg ti cann tfna 380mm/left-sterile.This is report 1 of 3 for (b)(4).

• Brand Name: 12MM/130 DEG TI CANN TFNA 380MM/LEFT-STERILE
• 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: 11195655
• Report Number: 2939274-2021-00370
• Device Sequence Number: 10954255
• Product Code: HSB
• UDI-Device Identifier: 10886982097392
• UDI-Public: (01)10886982097392
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 10/30/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.037.259S
• Device Catalogue Number: 04.037.259S
• Device Lot Number: 41P7959
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2020
• Initial Report FDA Received Date: 01/19/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention