MAUDE Adverse Event Report: INSERTION HANDLE FOR SUPRAPATELLAR; NAIL, FIXATION, BONE

Model Number	03.010.440
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes 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 an unknown date, during surgery the surgeon attempted to attach the impactor to the insertion handle.The impactor could not be attached to the insertion handle because the recess had the tip of a broken impactor stuck inside.This did not delay surgery because the surgeon could advance the nail without the impactor attached.This report involves one (1) insertion handle for suprapatellar.This is report 1 of 2 for (b)(4).

• Brand Name: INSERTION HANDLE FOR SUPRAPATELLAR
• Common Device Name: NAIL, FIXATION, BONE
• MDR Report Key: 12751046
• Report Number: 8030965-2021-09295
• Device Sequence Number: 1454860
• Product Code: JDS
• UDI-Device Identifier: 10886982068828
• UDI-Public: (01)10886982068828
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K111667
• 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
• Type of Report: Initial
• Report Date (Section B): 10/11/2021

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: 03.010.440
• Device Catalogue Number: 03.010.440
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2021
• Initial Report FDA Received Date: 11/04/2021
• 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: UNK - IMPACTION INSTRUMENTS: TRAUMA