MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM CANNULATED SCREW PARTIALLY THREADED/40MM; SCREW,FIXATION,BONE

Model Number	214.540
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Not Applicable (3189)
Date of Event	04/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is synthes sales consultant.Without a lot number the device history records review could not be completed.The received pictures were reviewed and the complained malfunction can be confirmed.It looks like the thread flanks of the cannulated screw did first peel off and then break off at the crossover to the shaft.Product was not returned and no lot number was provided, therefore no further evaluation is possible.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.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 canada as follows: it was reported that during an unknown procedure on (b)(6) 2020, the threads of 4.5mm cannulated screw 40mm (ss) stripped off of screw completely upon insertion over guide wire.There was an unspecified amount of surgical delay during the procedure.Fragments were generated, but were removed easily without additional intervention.Procedure was completed successfully.No further information provided.Concomitant devices reported: guide wire (part# unknown, lot# unknown, quantity# 1) screwdriver (part# unknown, lot# unknown, quantity# 1).This report is for 1 4.5mm cannulated screw partially threaded/40mm.This is report 1 of 1 for complaint (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.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: 4.5MM CANNULATED SCREW PARTIALLY THREADED/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: 10028693
• Report Number: 2939274-2020-02266
• Device Sequence Number: 11609656
• Product Code: HWC
• UDI-Device Identifier: 10886982154163
• UDI-Public: (01)10886982154163
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K161616
• 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
• Report Date (Section B): 04/22/2020

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: 214.540
• Device Catalogue Number: 214.540
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/22/2020
• Supplement Date Received by Manufacturer: 05/18/2020
• Initial Report FDA Received Date: 05/06/2020
• Supplement Report FDA Received Date: 05/18/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - GUIDE/COMPRESSION/K-WIRES; UNK - SCREWDRIVERS; UNK - GUIDE/COMPRESSION/K-WIRES; UNK - SCREWDRIVERS