MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA FENESTRATED SCREW 105MM - STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.038.205S
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional product code: ktt.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, it has been determined that no corrective and 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, (b)(4) jul 22, 2021, part number: 04.038.205s, lot number: h598895,, part manufacture date: apr 11, 2018, manufacturing location: (b)(4), part expiration date: mar 31, 2028, nonconformance noted: n/a.Dhr record review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of tfna fenestrated screw 105mm ¿ sterile product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.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.A review of the raw material device history record revealed this lot met all specifications with no nonconformance noted.This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.Device history batch: 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.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, the patient underwent for a surgery.During the surgery, while drilling with the stepped drill, the guide pin bound up inside of the drill bit on exit.While tapping the wire inside, the guide pin perforated the femoral head significantly into the pelvis.The guide pin was removed.The lag screw was then inserted and was too long possibly perforating the femoral head.The surgery was successfully completed.No fragments were generated.There were 10 minutes surgical delay.The patient outcome is unknown.Concomitant device reported.10/130 deg ti cann tfna 170 - sterile (part # 04.037.042s, lot# 231p163, qty 1).Unk insertion instrument (part# unknown, lot# unknown, qty 1).This complaint involves five (5) devices.This report is for (1) tfna fenestrated screw 105mm - sterile.This report is 1 of 3 for (b)(4).

• Brand Name: TFNA FENESTRATED SCREW 105MM - STERILE
• 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: 12274957
• Report Number: 2939274-2021-04473
• Device Sequence Number: 11722887
• Product Code: HSB
• UDI-Device Identifier: 10886982098795
• UDI-Public: (01)10886982098795
• Combination Product (Y/N): N
• 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): 07/07/2021

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: 04.038.205S
• Device Catalogue Number: 04.038.205S
• Device Lot Number: H598895
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/07/2021
• Initial Report FDA Received Date: 08/04/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 10/130 DEG TI CANN TFNA 170 - STERILE; 3.2MM GUIDE WIRE 400MM; 6MM/9MM CANNULATED STEPPED DRILL BIT; UNK - DRILL; UNK - GUIDES/SLEEVES/AIMING: GUIDE; UNK - GUIDES/SLEEVES/AIMING: GUIDE; UNK - INSERTION INSTRUMENTS: TRAUMA; UNK - SCREWS: LAG
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 69