MAUDE Adverse Event Report: SYNTHES GMBH RADIAL HEAD REPLACEMENT INSTRUMENT KIT, STERILE; PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER

Model Number	03.405.000S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
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.Date of event: only the event year is known.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.The initial 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
It was reported on an unknown date, during post op inspection, it was found that: 1) dhs coupling screw was bent from usage.2) plastic handle broke off as well during radial head planning.3) cutters were not able to cut.4) drill guides¿ threads were stripped.No patient consequence was reported.This report involves one radial head replacement instrument kit, sterile.This is report 1 of 1 for (b)(4).

• Brand Name: RADIAL HEAD REPLACEMENT INSTRUMENT KIT, STERILE
• Common Device Name: PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER
• 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: 15679224
• Report Number: 8030965-2022-08981
• Device Sequence Number: 5911718
• Product Code: KWI
• UDI-Device Identifier: 10886982300829
• UDI-Public: 10886982300829
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K183618
• 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

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: 03.405.000S
• Device Catalogue Number: 03.405.000S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/05/2022
• Initial Report FDA Received Date: 10/27/2022
• 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: 2.0 THRDD GUIDE F/ 2.7 SCR VA AND LCP.; CUTTING PLIERS.; DHS/DCS COUPLING SCREW.; WIRECUTTER LONG L230.
• Patient Sex: Unknown