MAUDE Adverse Event Report: SYNTHES GMBH PL 1-HO F/FEM NECK SYST TAN; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number 04.168.000S

Device Problem Migration (4003)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

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.Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j employee.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

It was reported, that on (b)(6) 2022, the patient underwent open reduction and internal fixation (orif) surgery with femoral neck system (fns) implants for femoral neck fracture.Although the surgeon acknowledged that the patient¿s bone quality was fragile, he chose to use fna implants to fix the fracture site.After surgery, the reduction position gradually collapsed, and cut-out occurred.The surgeon assumed that the cause of this event was the patient¿s bone quality.No further information is available.This report is for one (1) pl 1-ho f/fem neck syst tan this is report 2 of 4 for complaint (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.H6: a device history record (dhr) review was conducted: part #: 04.168.000s, lot #: 362p704, manufacturing site: jabil grenchen, release to warehouse date: 30, august 2021, expiry date: 01, august 2031.A manufacturing record evaluation was performed for the finished device lot and no non-conformance was 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: PL 1-HO 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 2540 ; SZ 2540
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15289390
• MDR Text Key: 298561086
• Report Number: 8030965-2022-05986
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 07612334089687
• UDI-Public: (01)07612334089687
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.168.000S
• Device Lot Number: 362P704
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: FEMORAL NECK SYSTEM PL 1 HOLE - STERILE; UNK - NAIL HEAD ELEMENTS: FNS ANTIROTATION; UNK - NAIL HEAD ELEMENTS: FNS BOLT; UNK - SCREWS: FNS LOCKING
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR
• Patient Sex: Female