MAUDE Adverse Event Report: SYNTHES GMBH EXTRACTION SCREW FOR PFNA BLADE; EXTRACTOR

Catalog Number	03.010.411
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Device report from synthes reports an event in spain as follows: it was reported that on (b)(6) 2023, there has been a problem when removing a pfna nail, specifically it has not been possible to remove the blade because the extractor for the blade could not be connected.When trying to connect it, it did not screw, as if it had been stripped, which made it impossible to connect the extractor.After trying in other ways, they could not get the nail out.The nail and the blade remained inside.There was a surgical delay of three (3) hours.This report involves one (1) extraction screw for pfna blade.This is report 1 of 2 for (b)(4).
Additional 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.H10 additional narrative: d9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.E1 initial reporter address line 1: (b)(6).E3: reporter is a j&j employee.H6: 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
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.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
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.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) 2023, there was a problem when removing a pfna nail, specifically it has not been possible to remove the blade because the extractor for the blade could not be connected.When trying to connect it, it did not screw, as if it had been stripped, which made it impossible to connect the extractor.After trying in other ways, they could not get the nail out.The nail and the blade remained inside.There was a surgical delay of three (3) hours.It was further reported that the nail had been put in at another hospital.The patient had osteomyelitis and had a diaphyseal fracture.A pfna was placed, a pseudoarthrosis was then performed and a femur liss plate was placed.In another subsequent surgery, a knee prosthesis was placed due to arthrosis.After this surgery, the patient developed an infection, which was also in the femur.Therefore, the doctor's intention was to remove the hardware, put in a spacer, and to drill and clean the femur.The patient was reported to be okay, and the doctor is waiting for the next step.

• Brand Name: EXTRACTION SCREW FOR PFNA BLADE
• Common Device Name: EXTRACTOR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 17878405
• Report Number: 8030965-2023-12631
• Device Sequence Number: 7389473
• Product Code: HWB
• UDI-Device Identifier: 07611819349483
• UDI-Public: 07611819349483
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,Followup,Followup

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: 03.010.411
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/03/2023
• Supplement Date Received by Manufacturer: 10/30/2023; 10/30/2023
• Initial Report FDA Received Date: 10/05/2023
• Supplement Report FDA Received Date: 10/30/2023; 10/30/2023
• 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: UNK - NAIL HEAD ELEMENTS: PFNA BLADE; UNK - NAIL HEAD ELEMENTS: PFNA BLADE; UNK - NAILS: PFNA; UNK - NAILS: PFNA; UNK - PLATES: LISS; UNK - SCREWS: LISS; UNK - SCREWS: NAIL DISTAL LOCKING
• Patient Sex: Male