MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CONICAL EXTRACTION SCREW FOR 2.7MM & 3.5MM CORTEX SCREWS; EXTRACTOR

Model Number	309.520
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient id also reported as (b)(6).Investigation summary: visual inspection: the conical extraction screw for 2.7 mm & 3.5 mm cortex screws (p/n 309.520 lot 2l96299) was received showing the distal threads stripped.No other issues were identified with the returned components of the device.Dimensional inspection: dimensional inspection of the distal threads could not be accurately conducted due to the post manufacturing damage/deformation.Document/specification review: the following drawings, reflecting the manufactured and current revision, were reviewed.Extraction screw, conical se.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.Conclusion: the complaint condition is confirmed for the conical extraction screw for 2.7 mm & 3.5 mm cortex screws (p/n 309.520 lot 2l96299) as the distal threads were stripped.While no definitive root cause could be determined, it is possible that the device encountered excessive torque/cross threading/rough handling during device use.During this investigation no product design or manufacturing issues were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history lot: part: 309.520.Lot: 2l96299.Manufacturing site: (b)(4).Release to warehouse date: march 14, 2019.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, the cannulated hexagonal power screwdriver to the 6.5 mm cannulated screws broke at the tip during a pelvis reconstruction case.Also, the 2.5 hexagonal conical extractor was stripped during the poly trauma procedure.There were fragments generated from a broken device.There was no other required medical intervention.There was no surgical delay.The procedure was successfully completed.There was no patient consequence.Concomitant device reported: unknown 6.5 mm cannulated screws(part#unknown, lot#unknown, quantity unknown).This is report 2 for 2 (b)(4).

• Brand Name: CONICAL EXTRACTION SCREW FOR 2.7MM & 3.5MM CORTEX SCREWS
• Common Device Name: EXTRACTOR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8974876
• Report Number: 2939274-2019-60400
• Device Sequence Number: 188815
• Product Code: HWB
• UDI-Device Identifier: 10886982185822
• UDI-Public: (01)10886982185822
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/12/2019

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: 309.520
• Device Catalogue Number: 309.520
• Device Lot Number: 2L96299
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/12/2019
• Initial Report FDA Received Date: 09/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWS: 6.5 MM AND 7.3 MM CANNULATED
• Patient Age: 15 YR
• Patient Weight: 111