MAUDE Adverse Event Report: SYNTHES GMBH TFNA HELICAL BLADE L95 TAN; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 04.038.295S

Device Problem Migration (4003)

Patient Problem Pain (1994)

Event Date 02/01/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j sales representative.A review of the device history record has been completed.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) 2019, the patient underwent surgery for trochanteric fracture of femur with tfna.After surgery, on unknown date, the patient fell.In early (b)(6) 2022, when the patient visited the hospital because of pain due to fall, an x-ray was taken, and the cut-out was found.However, the patient had dementia and it was unknown if the cut-out occurred when the patient fell or for any other reason.On (b)(6) 2022, the removal surgery of tfna was performed.The removal surgery was completed successfully with no surgical delay.Since the patient is a wheelchair user, and in the future, conservative treatment will be kept if the patient does not have pain, and tha will be performed if the patient has pain.No further information is available.This complaint involves one (1) device tfna helical blade l95 tan.This is report 1 of 1 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.H10: additional narrative: h3, h4, h6: part 04.038.295s, lot: h713605: manufacturing site: werk selzach logistik.Release to warehouse date: august 28, 2018.Expiration date: august 01, 2028.Supplier: synthes usa hq, inc.A manufacturing record evaluation was performed for the non-sterile article lot and no non-conformances were identified.H3, h6: a photo investigation was completed: visual analysis of the provided photo revealed that tfna helical blade is located high in the head in a cut out which indicates that it was migrated from its original spot.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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: TFNA HELICAL BLADE L95 TAN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13669063
• MDR Text Key: 290567132
• Report Number: 8030965-2022-01380
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819652453
• UDI-Public: (01)07611819652453
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.038.295S
• Device Lot Number: H713605
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2018
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: TFNA FEM NAIL Ø12 130° L170 TIMO15.; UNK - SCREWS: NAIL DISTAL LOCKING.
• Patient Outcome(s): Required Intervention