MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC EXTRACTION BOLT FOR 6.5MM & 7.0MM SCREWS; EXTRACTOR

Model Number	309.069
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: investigation flow: damage.Visual inspection: the extraction bolt for 6.5mm & 7.0mm screws (part # 309.069/ lot # l862300) was received at us cq.The distal tip of the device was broken, the broken fragment was also received.The breakage was sagittal in nature.Approximately 1/3rd of the tip broke off.One of the sections of the tip was deformed inward.The distal circumference was not consistent/smooth due to the observed deformation.The received condition was consistent with the complaint condition thus the complaint was confirmed.Device failure/defect identified? yes; tip was broken and deformed.Dimensional inspection: dimensional inspection was not performed due to post-manufacturing damage.Document/specification review: drawing(s) reviewed: (current & manufactured revisions).Conclusion: the overall complaint was confirmed for the received extraction bolt for 6.5mm & 7.0mm screws as the tip was broken and deformed.Although no definitive root-cause can be determined, the inward bend on the tip suggests the device may have experienced unintended forces leading to the breakage.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot: part: 309.069, lot: l862300, manufacturing site: (b)(4), release to warehouse date: jun.08, 2018, expiry date: aug.01, 2026.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified.Device history review: review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which 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 an unknown date, the doctor was using extraction bolt from the broken screw removal set.As the surgeon was turning it counterclockwise to attach it to the broken screw, a piece of the bolt broke off.The surgeon opened another broken screw removal set and used an unknown 6.5/7.0 hollow reamer out of it.There were no fragments generated.There was no surgical delay.Procedure successfully completed.Patient outcome is unknown.Concomitant device reported: unk - screw (part # unknown, lot # unknown, quantity # 1).This complaint one (1) device.This is 1 of 1 for report (b)(4).

• Brand Name: EXTRACTION BOLT FOR 6.5MM & 7.0MM 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: 9820273
• Report Number: 2939274-2020-01215
• Device Sequence Number: 3069207
• Product Code: HWB
• UDI-Device Identifier: 10886982185594
• UDI-Public: (01)10886982185594
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/13/2020

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: 309.069
• Device Catalogue Number: 309.069
• Device Lot Number: L862300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2020
• Initial Report FDA Received Date: 03/11/2020
• Patient Sequence Number: 1