MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.0MM CANNULATED SCREW SHORT THREAD/40MM; SCREW,FIXATION,BONE

Model Number	207.640
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Code Available (3191)
Date of Event	10/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/ investigation.(b)(4).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.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, during open reduction internal fixation surgery of the patella, the cannulated screw short threaded broke off during insertion on power.Surgeon was using the cannulated power shaft.Patient had tough bone.Fragments were generated from broken device.Broken device was centrally located in the patella.The thread is still engaged in the patient.There was no surgical delay.Procedure was successfully completed.Patient outcome was unknown.This complaint involves one (1) device.This report is for one (1) 4.0 mm cannulated screw short thread/ 40mm.This is report 1 of 1 for (b)(4).
Event or Problem Description
There is no plan to remove the thread from the patient.Concomitant devices: hand piece powered driver (part: unknown, lot: unknown, quantity: 1).
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.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: 4.0MM CANNULATED SCREW SHORT THREAD/40MM
• 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: 9315459
• Report Number: 2939274-2019-62145
• Device Sequence Number: 606772
• Product Code: HWC
• UDI-Device Identifier: 10886982148247
• UDI-Public: (01)10886982148247
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K963192
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2019

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: 207.640
• Device Catalogue Number: 207.640
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/08/2019
• Supplement Date Received by Manufacturer: 11/18/2019
• Initial Report FDA Received Date: 11/13/2019
• Supplement Report FDA Received Date: 12/04/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - POWERED DRIVERS/HANDPIECES
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 23 YR