MAUDE Adverse Event Report: SYNTHES GMBH CONNECTING SCREW/ CANNULATED MEDIUM; NAIL, FIXATION, BONE

Model Number	03.043.022
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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 pro-code: hwc.Complainant part is not expected to be returned for manufacturer review/investigation.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) 2022, during a intra-op case while utilizing the compression device in our ans tna parapatellar set, the compression device would not disengage from the connecting screw.The surgeon proceeded to remove the two devices together as a unit and subsequently thread in a new connecting screw from the tray.Maybe a 10 second delay or addition to surgical time.However, we sterile processing reported that the compression device and connecting screw were still completely threaded together and as such, left out of our instrument set.They tried soaking the instruments to loosen them, clamping them to get better torque for disengagement, etc.To no avail.The lot #s is not available as the compression device is still inside and thus not visible, the connecting screw that had some sort of clamp on it during the attempt to disengage sustained damage which skews the visibility of the lot #.Patient consequences or surgery results are unknown.This complaint involves two (2) devices.This report is for one (1) connecting screw/ cannulated medium.This is report 2 of 2 for complaint (b)(4).

• Brand Name: CONNECTING SCREW/ CANNULATED MEDIUM
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16189831
• Report Number: 8030965-2023-00591
• Device Sequence Number: 20326478
• Product Code: JDS
• UDI-Device Identifier: 10886982297211
• UDI-Public: (01)10886982297211
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Physician
• 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: 03.043.022
• Device Catalogue Number: 03.043.022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/23/2022
• Initial Report FDA Received Date: 01/17/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CONNECTING SCREW/ CANNULATED MEDIUM
• Patient Sex: Unknown