MAUDE Adverse Event Report: SYNTHES GMBH 5.0 PERIPRO VAL SCR SLF-TPNG/SD/18; SCREW, FIXATION, BONE

Model Number	02.231.018
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on an unknown date, the elevators were bent in sterile processing wash.The second items, screwdrivers, were completely stripped out and unusable.Screwdriver is also stripped out and needs replacing.The last item screw is a hand torque longing handle and the quick connect has bent and no longer accepts a shaft.There was no patient involvement.This report is for one (1 ) 5.0 peripro val scr slf tpng/sd/18 this is report 2 of 2 for complaint (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).Epuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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.Additional narrative: reporter is a j&j employee.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.

• Brand Name: 5.0 PERIPRO VAL SCR SLF-TPNG/SD/18
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16674049
• Report Number: 8030965-2023-04066
• Device Sequence Number: 15047777
• Product Code: HWC
• UDI-Device Identifier: 10886982061898
• UDI-Public: (01)10886982061898
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K110354
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/04/2023

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: 02.231.018
• Device Catalogue Number: 02.231.018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/14/2023
• Initial Report FDA Received Date: 04/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5MM HEX SCREWDRIVER SHAFT; PERIOSTEAL ELVTR 14 STR BLD-ROUND EDGE; PERIOSTEAL ELVTR 14 STR BLD-ROUND EDGE; PERIOSTEAL ELVTR 14 STR BLD-ROUND EDGE; T15 CANN STRDRV SCRWDRVR SFT SLF-RETAIN; T15 CANN STRDRV SCRWDRVR SFT SLF-RETAIN
• Patient Sex: Unknown