MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.0MM CANNULATED SCREW SHORT THREAD/46MM; SCREW, FIXATION, BONE

Model Number	207.646
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient identifier: (b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.Manufacturing location: (b)(4), manufacturing date: october 10, 2017, part number: 207.646, 4.0 mm cannulated screw short thread 46 mm.Lot number: h474023 (non-sterile), lot quantity: 86.Three pieces were scrapped in cell at op #20, mill threads, for a set-up failure.Five pieces were scrapped in cell at op #50, grind flutes, after a machine malfunction.Work order traveler met all inspection acceptance criteria apart from the eight pieces noted.Inspection sheet, inspect turn wobble broach, mill threads, grind flutes / final inspection met all inspection acceptance criteria.Packaging label log lppf, lmd/lpf was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.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.Component part(s) reviewed: part number: 16014, 316l**hi6.00x1.40, lot number: h147084, lot quantity: 1,820 ft.Material certificate supplied by sandvik materials technology dated june 24, 2016 was reviewed and determined to be conforming.Lot summary report dated july 24, 2016 met all inspection acceptance criteria.Raw material receiving/putaway checklist met all inspection acceptance criteria.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.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.(b)(4).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) 2020, during an unknown procedure for a patient with a fractured left patella, the cannulated screw broke off as it was being implanted into the patella.A partial part of the screw was explanted by the surgeon.The distal tip of the screw was embedded into the patella and the surgeon was unable to remove it.The procedure was successfully completed with no surgical delay.There were no complications with the patient and the distal end of the screw was left in the patient.Concomitant devices reported: screwdriver (part number unknown, lot unknown, quantity 1).This report involves one (1) 4.0 mm cannulated screw short thread/46 mm.This is report 1 of 1 for (b)(4).

• Brand Name: 4.0MM CANNULATED SCREW SHORT THREAD/46MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10465172
• Report Number: 2939274-2020-03852
• Device Sequence Number: 2404179
• Product Code: HWC
• UDI-Device Identifier: 10886982148278
• UDI-Public: (01)10886982148278
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K161616
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/04/2020

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: 207.646
• Device Catalogue Number: 207.646
• Device Lot Number: H474023
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/04/2020
• Initial Report FDA Received Date: 08/28/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 29 YR
• Patient Weight: 78