MAUDE Adverse Event Report: SYNTHES GMBH 10MM / TI CANN FRN / GT 420MM / LEFT - STERILE; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.033.073S

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/16/2021

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021 the patient underwent a femoral recon nail procedure treating midshaft fracture.During the procedure, the femoral recon nail, unknown nail insertion handle, unknown guidewire, unknown recon screw, and unknown drill guide were unable to align correctly.Upon inserting the unknown recon screws into the femoral head through the inferior screw option, the unknown guidewires and unknown recon drill kept hitting the nail.The nail was adjusted twice to try and prevent it hitting without success.The surgeon decided to change his locking option and chose the antegrade and transverse options.It was commented that the surgeon thought he was leaning on the insertion guide too much, causing the drill guides to diverge and allowing the guide wire to hit the nail.There was a surgical delay of forty-five (45) minutes.The procedure was successfully completed by removing the nail and reinserting.Patient outcome is unknown.This report is for one (1) 10mm / ti cann frn / gt 420mm / left - sterile.This is report 1 of 5 for (b)(4).

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d10.H6: part: 04.033.073s.Lot: l928150.Manufacturing site: werk bettlach.Release to warehouse date: june 22, 2018.Expiration date: june 01, 2028.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Product was not returned.Based on the information available, it has been determined that no corrective and 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: 10MM / TI CANN FRN / GT 420MM / LEFT - STERILE
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12464935
• MDR Text Key: 271246634
• Report Number: 8030965-2021-07669
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07612334123947
• UDI-Public: (01)07612334123947
• Combination Product (y/n): N
• PMA/PMN Number: K172157
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/16/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: 04.033.073S
• Device Lot Number: L928150
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/16/2021
• Initial Date FDA Received: 09/13/2021
• Supplement Dates Manufacturer Received: 09/16/2021
• Supplement Dates FDA Received: 10/12/2021
• Patient Sequence Number: 1
• Treatment: UNK - GUIDE/COMPRESSION/K-WIRES; UNK - GUIDE/COMPRESSION/K-WIRES; UNK - NAIL HEAD ELEMENTS: FRN RECON SCREW; UNK - NAIL HEAD ELEMENTS: FRN RECON SCREW; UNK - NAIL INSERTION HANDLES; UNKNOWN - DRILL BIT; UNKNOWN - DRILL BIT