MAUDE Adverse Event Report: SYNTHES GMBH UNK - NAILS: TFNA; ROD, FIXATION, INTRAMEDULLARY

Device Problem Device-Device Incompatibility (2919)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Date 10/25/2020

Event Type  Injury  

Manufacturer Narrative

This report is for an unk - nails: tfna/unknown lot.Part and lot numbers are unknown; udi 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 as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(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 india reports an event as follows: it was reported that on (b)(6) 2020, the patient underwent for a tfna surgery.During the surgery, after reaming for the blade was done , the blade was inserted, and it got stuck before getting completely inserted.Blade neither moved forward nor the blade got removed using the removal instruments.Finally, the portion of the blade which was protruding out laterally was cut by the surgeon.While hammering the spiral blade over the guide wire it got stuck in between and neither was it going in nor was it coming out in spite of repeated attempts.It was almost cold welded with the nail.The surgery was completed successfully with 60-90 minutes delay.It was unknown if fragments were removed without any additional intervention.The patient outcome was unknown.Concomitant device reported: unknown nail insertion handles (part#: unknown, lot#: unknown, quantity: 1).Unknown drill (part#: unknown, lot#: unknown, quantity: 1).Unknown hammer/mallet (part#: unknown, lot#: unknown, quantity: 1).Unknown aiming arm (part#: unknown, lot#: unknown, quantity: 1).This complaint involves three (3) devices.This report is for (1) unk - nails: tfna.This is report 3 of 3 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.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.H6: reviewing attached picture, the complaint description can be confirmed the tfna blade is cut and the blade tip is implanted at the x-ray visible.Just based on the picture it is not possible to confirm a functional issue, therefore the complaint is rated as n/a in the confirmed field.Product was not returned.Based on the information available, it has been determined that no corrective and 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.

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.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: UNK - NAILS: TFNA
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10869327
• MDR Text Key: 217438367
• Report Number: 8030965-2020-09076
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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,Followup
• Report Date: 10/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/25/2020
• Initial Date FDA Received: 11/19/2020
• Supplement Dates Manufacturer Received: 11/19/2020; 12/17/2020; 03/10/2022
• Supplement Dates FDA Received: 11/30/2020; 01/12/2021; 03/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: TFNA HELICAL BLADE PERF L105 TAN; UNK - DRILL; UNK - GUIDE/COMPRESSION/K-WIRES; UNK - GUIDES/SLEEVES/AIMING: AIMING ARM; UNK - IMPACTION INSTRUMENTS: HAMMER/MALLET: TRAUMA; UNK - NAIL INSERTION HANDLES
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male