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

Catalog Number 03.010.411

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/01/2021

Event Type  Injury  

Manufacturer Narrative

Patient's birth year: 1953.This report is for an unknown extraction instrument/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.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 Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that in (b)(6) 2020 a patient underwent the surgery to treat the subtrochanteric femur fracture with a marrow nail osteosynthesis (synthes proximal femoral nail (pfn) alpha).The patient suffers from slow progressive arthrosis and requested the nail construct to be removed despite clinically low symptoms.Pre-operative information about a possible one-sided procedure in case of later necessity of hip replacement has been provided; nevertheless, the patient wanted the material to be removed to make a possible future tep treatment easier.Material removal was done on (b)(6) 2021.During the procedure it was easy to find the blade end in the thigh, insert the guide wire and completely expose the blade end of scar tissue.While doing the attachment of the extraction screw via the guide wire (anti-clockwise); the thread broke off in the blade end without significant force, therefore the extraction screwdriver could no longer be fastened.The material removal had then to be canceled.The nail and blade remained in the patient.No fragments were created.The surgeon suspects a cold weld of nail and blade.Patient outcome is reported as good.This report is for one (1) unknown extraction instrument.This is report 1 of 1 for complaint (b)(4).

Event Description

Updated event description.Concomitant device reported.Combined hammer 500g f/03.010.170 (part# 03.010.170, lot# 8843406, qty 1).Unk - cable/wire (part# unknown, lot# unknown, qty1).

Manufacturer Narrative

Product complaint # (b)(4).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: b5: updated event description.D1, d2a, d2b, d4: updated.G1: updated.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.

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.Device history lot part: 03.010.411 lot: 84p9653 manufacturing site: bettlach release to warehouse date: 03 march 2021 a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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: EXTRACTION SCREW FOR PFNA BLADE
• Type of Device: EXTRACTOR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 12508255
• MDR Text Key: 272538260
• Report Number: 8030965-2021-07901
• Device Sequence Number: 1
• Product Code: HWB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.010.411
• Device Lot Number: 84P9653
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: COMBINED HAMMER 500G F/03.010.170; UNK - CABLE/WIRE; UNK - CABLE/WIRE; UNK - NAIL HEAD ELEMENTS: PFN BLADE; UNK - NAIL HEAD ELEMENTS: PFN BLADE; UNK - NAILS: PFNA; UNK - CABLE/WIRE; UNK - NAIL HEAD ELEMENTS: PFN BLADE
• Patient Outcome(s): Required Intervention
• Patient Sex: Female