MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.0MM CANNULATED SCREW LONG THREAD/48MM; SCREW, FIXATION, BONE

Model Number	207.748
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j sales representative.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) 2021, patient underwent a surgical procedure for an unknown reason.4.0mm cannulated screw long thread was inserted.Upon taking the x-ray, doctor noticed long hard metal coming out of the cannulated screw.Product is still in the patient but removed from the patients bone.Concomitant device reported: unknown screwdriver (part# unknown; lot# unknown; quantity: i).This report is for one (1) 4.0mm cannulated screw long thread/48mm.This is report 1 of 1 for complaint (b)(4).
Event or Problem Description
After removing the metal shaving no further action was taken and the patient will continue to be monitored.The patient outcome was unknown.
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 LONG THREAD/48MM
• 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: 11769905
• Report Number: 2939274-2021-02209
• Device Sequence Number: 17088451
• Product Code: HWC
• UDI-Device Identifier: 10886982148544
• UDI-Public: (01)10886982148544
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: PRE-AMEND
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2021

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: 207.748
• Device Catalogue Number: 207.748
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/07/2021
• Supplement Date Received by Manufacturer: 05/04/2021
• Initial Report FDA Received Date: 05/04/2021
• Supplement Report FDA Received Date: 06/01/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWDRIVERS
• Outcome Attributed to Adverse Event: Required Intervention