MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - EXTRACTION INSTRUMENTS: TRAUMA; EXTRACTOR

Device Problems Device-Device Incompatibility (2919); Material Twisted/Bent (2981)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Date 07/07/2020

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown extraction instrument/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.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.(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 Description

Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2020 that a tibial nail was removed from the patient.The extraction screw was faulty due to the threads.An additional extraction screw was used however the thread on the nail had been destroyed.A guide wire was put down and an extraction conical bolt was used to remove the nail.There was a surgical delay of sixty (60) minutes and the procedure was completed successfully.This report is for one (1) unknown extraction instrument.This is report 3 of 3 for (b)(4).

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: g4: awareness date on initial reported as july 06, 2020 but should have been july 07, 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.

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.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: UNK - EXTRACTION INSTRUMENTS: TRAUMA
• Type of Device: EXTRACTOR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10320106
• MDR Text Key: 200225281
• Report Number: 2939274-2020-03293
• Device Sequence Number: 1
• Product Code: HWB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/07/2020

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/06/2020
• Initial Date FDA Received: 07/24/2020
• Supplement Dates Manufacturer Received: 08/12/2020; 09/09/2020
• Supplement Dates FDA Received: 09/07/2020; 09/09/2020
• Patient Sequence Number: 1
• Treatment: EXTRACTSCR F/TIBIAL+FEM NAILS; UNK - NAILS: TIBIAL
• Patient Outcome(s): Required Intervention