MAUDE Adverse Event Report: SYNTHES GMBH PL 2HO F/FEM NECK SYST TAN; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number 04.268.000S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Limb Fracture (4518)

Event Date 07/13/2022

Event Type  Injury  

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Complainant part is not expected to be returned for manufacturer review/investigation.Postal code (b)(6).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 japan as follows: it was reported that on (b)(6) 2022, the patient underwent the orif surgery with the plate for femoral neck fracture.After surgery, on (b)(6) 2022, the patient fell at a rehabilitation facility, and subtrochanteric fracture of femur was confirmed.On (b)(6) 2022, a revision surgery will be performed with a recon nail and cannulated screws.The surgeon commented as follows.Since the patient had fallen, the surgeon does not think that this subtrochanteric femoral fracture was caused by the implant.However, a locking screw was inserted closer to anterior, which might have had different results if it had been inserted in the center.No further information is available.Concomitant device reported: unk - screws: locking(part# unknown; lot# unknown; quantity: unknown).This report is for one (1) pl 2ho f/fem neck syst tan.This is report 1 of 1 for complaint (b)(4).

• Brand Name: PL 2HO F/FEM NECK SYST TAN
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK GRENCHEN (CH); solothurnstrasse 186; grenchen
• Manufacturer Contact: kate karberg ; eimattstrasse 3; oberdorf ; SZ ; 6103142063
• MDR Report Key: 15190284
• MDR Text Key: 297499940
• Report Number: 8030965-2022-05646
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 07612334090058
• UDI-Public: (01)07612334090058
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K172872
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.268.000S
• Device Lot Number: 619P968
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - SCREWS: LOCKING
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR
• Patient Sex: Female