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

Model Number 387.34

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/17/2020

Event Type  malfunction  

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 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
• Type of Device: TRAY,SURGICAL INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10208834
• MDR Text Key: 202594106
• Report Number: 2939274-2020-03028
• Device Sequence Number: 1
• Product Code: FSM
• UDI-Device Identifier: 10705034771083
• UDI-Public: (01)10705034771083
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 387.34
• Device Catalogue Number: 387.34
• Device Lot Number: U321447
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2018
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1