MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CONICAL EXTRACTION SCREW; TRAY,SURGICAL INSTRUMENT

Model Number	387.34
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: product was not returned.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: part number: 387.34, connical extraction screw, lot number: u321447 (non-sterile), lot quantity: (b)(4) total.Manufacturing location: supplier: (b)(4), inspected and released by: (b)(4), release to warehouse date(s): 13-nov-2018, quantity (b)(4), 19-nov-2018 quantity (b)(4), 15-jan-2019 quantity (b)(4).Purchased finished goods travelers met all in inspection acceptance criteria.Certificates of conformance supplied by (b)(4) dated 02-nov-2018 were reviewed and determined to be conforming.Hardness specified at 50-55 hrc and results certified at 51.46 hrc.Inspection sheets, met all inspection acceptance criteria.Packaging / labeling was verified during inspection per inspection sheet requirements.This lot met all visual and packaging criteria at the time of release with no issues documented during the inspection or release of the product that would contribute to this complaint condition.This lot met all visual and packaging criteria at the time of release with no issues documented during the inspection or release of the product 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 during a hardware removal of a smith and nephew intertan nail on (b)(6) 2020, one of the head of the intertan lag screws broke during the removal process.A series of multiple attempts to extract the lag screw was made but unsuccessful.The surgeon decided to do a proximal femur replacement which involved cutting the nail out due to not being able to remove the intertan nail.During the process an instrument from the screw removal was used to try to remove the lag screw but the tip of the reported conical extraction screw broke off into the lag screw.All of the broken fragments of the conical extraction screw were removed easily from the patient.The broken screw removal tool did not cause any disruption or harm to the patient or change the course of the procedure.The procedure was successfully completed without a surgical delay.Concomitant device reported: unknown lag screw (part # unknown, lot # unknown, quantity 1) this is report 1 of 1 for (b)(4).

• Brand Name: CONICAL EXTRACTION SCREW
• Common Device Name: TRAY,SURGICAL INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10208834
• Report Number: 2939274-2020-03028
• Device Sequence Number: 16677692
• Product Code: FSM
• UDI-Device Identifier: 10705034771083
• UDI-Public: (01)10705034771083
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 387.34
• Device Catalogue Number: 387.34
• Device Lot Number: U321447
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/17/2020
• Initial Report FDA Received Date: 06/29/2020
• Patient Sequence Number: 1