MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC EXTRACTION BOLT FOR 2.7MM CORTEX SCREWS; EXTRACTOR

Model Number	309.290
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.Device is not distributed in the united states but is similar to device marketed in the usa.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
Device report from synthes reports an event in (b)(4) as follows: it was reported on an unknown date that the patient was underwent a surgery to remove broken screw from the ankle.The bone is healed but surgeon wanted to remove the broken screw body out from bone matrix.Despite the fact technique guide does recommend the use of extraction bolt (designed for 2.7mm cortical screws) to extract 2.4mm cortical screw body but couldn't remove it.The extraction bolt couldn't grab the screw as it designs for.The extraction bolt used could not remove the screw.Thus, the distal part of the screw remained in the patient.After the surgery was over, surgeon tried to use extraction bolt 309.190 to see if could have used this bolt rather than 309.290.Surgeon has used it over the proximal part of the screw (removed from patient).It could grab the screw body but once tried to remove it from the 309.190 extraction bolt, the screw body shear off within the extraction bolt.Extraction bolt is now defective.There was no reported delay.There was no patient consequence.This is report 2 of 3 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 corrected data: b3: event year is reported as 2019; however exact date of event is unknown.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
This report captures the event that happened intraoperatively wherein extraction bolt could not remove the broken cortex screw body from the bone matrix and the other extraction bolt that sheared the removed proximal part of the screw and became defective wile related complaint (b)(4) for the event wherein the cortex screw broke post-operative.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: h3, h6: investigation summary 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.H11:d10: complainant part is not expected to be returned for manufacturer review/investigation.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.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H11: corrected data: g4: awareness date reported on follow up 1 report as december 08, 2019 but should have been january 06, 2020.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.

• Brand Name: EXTRACTION BOLT FOR 2.7MM 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: 9536001
• Report Number: 2939274-2019-62811
• Device Sequence Number: 11371700
• Product Code: HWB
• UDI-Device Identifier: 10886982185716
• UDI-Public: (01)10886982185716
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/08/2019

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: 309.290
• Device Catalogue Number: 309.29
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/08/2019
• Supplement Date Received by Manufacturer: 12/08/2019; 01/28/2020; 01/29/2020
• Initial Report FDA Received Date: 12/31/2019
• Supplement Report FDA Received Date: 01/27/2020; 01/28/2020; 02/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1