MAUDE Adverse Event Report: SYNTHES GMBH EXTRACTION SCREW FOR MULTILOC HUMERAL NAILING SYSTEM; ROD,FIXATION,INTRAMEDULLARY

Model Number	03.019.024
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional procode: hrs, hwc.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a j&j employee.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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021 during an unknown procedure, the extraction screw had a worn thread making it unable to extract the nail.The procedure was successfully completed without surgical delay.There was no patient consequence.Concomitant device: unknown humeral nail (part# unknown; lot# unknown; quantity: 1).This report is for one (1) extraction screw for multiloc humeral nailing system.This is report 1 of 1 for (b)(4).

• Brand Name: EXTRACTION SCREW FOR MULTILOC HUMERAL NAILING SYSTEM
• Common Device Name: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11392973
• Report Number: 8030965-2021-01479
• Device Sequence Number: 1165567
• Product Code: HSB
• UDI-Device Identifier: 10886982069634
• UDI-Public: 10886982069634
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K120807
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/04/2021

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: 03.019.024
• Device Catalogue Number: 03.019.024
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 03/01/2021
• Patient Sequence Number: 1