MAUDE Adverse Event Report: SYNTHES GMBH TFNA HELICAL BLADE 90MM STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 04.038.290S

Device Problem Use of Device Problem (1670)

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

Event Date 10/29/2020

Event Type  Injury  

Manufacturer Narrative

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.(b)(4).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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2020 that the patient underwent surgery for a femoral trochanteric fracture (intramedullary fracture).During the surgery, after the 90mm blade locking screw and endcap were inserted, it was discovered by the image intensifier that the 90mm blade reached the subchondral bone.The 90mm blade was removed and the bone was filled by reaming into the bone head.A new 85mm blade was inserted and the surgery was completed successfully within a thirty (30) minute delay.Concomitant devices: unknown tfna nail (part # unknown, lot # unknown, quantity 1).Unknown tfna end cap (part # unknown, lot # unknown, quantity 1).Unknown locking screw (part # unknown, lot # unknown, quantity unknown).This report is for one (1) tfna helical blade 90mm sterile.This is report 1 of 1 for (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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

Updated event description: patient outcome was stable.

• Brand Name: TFNA HELICAL BLADE 90MM STERILE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10899669
• MDR Text Key: 218245758
• Report Number: 8030965-2020-09170
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K131548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.038.290S
• Device Lot Number: 43P9243
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/25/2020
• Patient Sequence Number: 1
• Treatment: UNK - END CAPS: TFNA; UNK - NAILS: TFNA; UNK - SCREWS: LOCKING; UNK - END CAPS: TFNA; UNK - NAILS: TFNA; UNK - SCREWS: LOCKING
• Patient Outcome(s): Required Intervention
• Patient Age: 89 YR
• Patient Weight: 37