MAUDE Adverse Event Report: HAGENDORF SYNTHES PRODUKTIONS GMBH CONNECTING SCREW/ CANNULATED SHORT; SCREW, FIXATION, BONE

Model Number	03.043.019
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
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 unknown date,after post op inspection the treys in this specific wash cycle in cspd were damaged.Two graphic cases were slimy & appeared covered with a white chalk texture that were unable to be removed.Insertion handle and connecting screw had residue along with the suprapatellar guides.The surgery was successfully completed.Patient outcome is stable.This report is for one (1) connecting screw/ cannulated short.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.Additional narrative: procode: additional product code: jds.Device available for evaluation: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Initial reporter occupation: reporter is a j&j sales representative.Postal code: (b)(6).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: CONNECTING SCREW/ CANNULATED SHORT
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): HAGENDORF SYNTHES PRODUKTIONS GMBH; im bifang 6; hagendorf 4614 ; SZ 4614
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf
• Manufacturer Contact: kate karberg ; in bifang 6; hagendorf ; SZ ; 6103142063
• MDR Report Key: 15259135
• Report Number: 8030965-2022-05880
• Device Sequence Number: 5787039
• Product Code: HWC
• UDI-Device Identifier: 10886982297181
• UDI-Public: (01)10886982297181
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K201336
• 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: 03.043.019
• Device Catalogue Number: 03.043.019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/22/2022
• Initial Report FDA Received Date: 08/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown