MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CANNULATED CONNECTING SCREW F/TROCHANTERIC FIXATION NAILS; GUIDE, SURGICAL, INSTRUMENT

Model Number	357.397
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from depuy synthes reports an event in (b)(6) as follows: it was reported that on an unknown date a patient underwent the surgery with a short titanium trochanteric fixation nail system (tfn) to treat a hip fracture.During the procedure when surgeon tried to insert the distal locking screw it missed the nail.He removed the nail and reconnected the instruments but it continued to miss the nail.The surgeon finally inserted the screw with a freehand technique.The surgery was delayed for five (5) minutes due to the reported event.The procedure was successfully completed.No patient consequence reported.This report is for one (1) cannulated connecting screw f/trochanteric fixation nails this is report 1 of 5 for complaint (b)(4).
Additional Manufacturer Narrative
If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.
Additional Manufacturer Narrative
Additional narrative: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 depuy synthes reports an event in (b)(6) as follows: it was reported that on an unknown date a patient underwent the surgery with a short titanium trochanteric fixation nail system (tfn) to treat a hip fracture.During the procedure when surgeon tried to insert the distal locking screw it missed the nail.He removed the nail and reconnected the instruments but it continued to miss the nail.The surgeon finally inserted the screw with a freehand technique.The surgery was delayed for five (5) minutes due to the reported event.The procedure was successfully completed.No patient consequence reported.This report is for one (1) cannulated connecting screw f/trochanteric fixation nails this is report 1 of 5 for complaint (b)(4).

• Brand Name: CANNULATED CONNECTING SCREW F/TROCHANTERIC FIXATION NAILS
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 13476705
• Report Number: 2939274-2022-00383
• Device Sequence Number: 5247218
• Product Code: FZX
• UDI-Device Identifier: 10886982196224
• UDI-Public: (01)10886982196224
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,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: 357.397
• Device Catalogue Number: 357.397
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/10/2022
• Initial Report FDA Received Date: 02/07/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AIM-ARM F/TFN 130°; INSRT H&LE F/TROCHANTERIC FIXATION NAILS; UNK - NAILS: TFN; UNK - SCREWS: NAIL DISTAL LOCKING
• Patient Sex: Unknown