MAUDE Adverse Event Report: CONNECSCR CANN SHORT F/TIBNAIL F/03.010.; NAIL, FIXATION, BONE

Catalog Number	03.010.095
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: 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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021 during a tibia osteosynthesis surgery, there was a misalignment of the proximal locking of an unknown expert tibial nail with the connecting screw.The insertion handle and aiming arm were unable to disassemble.The procedure was successfully completed.There was no patient consequence.This report is for one (1) connecscr cann short f/tibnail f/03.010.This is report 3 of 4 for (b)(4).

• Brand Name: CONNECSCR CANN SHORT F/TIBNAIL F/03.010.
• Common Device Name: NAIL, FIXATION, BONE
• MDR Report Key: 12705570
• Report Number: 2939274-2021-06332
• Device Sequence Number: 17277595
• Product Code: JDS
• UDI-Device Identifier: 07611819761162
• UDI-Public: (01)07611819761162
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• PMA/510(K) Number: K040762
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 10/01/2021

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 Catalogue Number: 03.010.095
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/01/2021
• Initial Report FDA Received Date: 10/27/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AIM-ARM F/ETN; INSERT-HANDLE RADIOLUC F/ETN; UNK - NAILS: EXPERT TIBIAL