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

Device Problem Break (1069)

Patient Problem Unspecified Tissue Injury (4559)

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.Investigation summary: the narrative could not be confirmed based on the received picture.It is not possible to identify that the tfna nail is broken.Just based on the x-ray it is not possible to confirm a functional issue of the tfna nail, 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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, the tfna nail broke.There was patient consequence.There is no further information available.This report is for (1) unk - nails: tfna.This is report 1 of 1 for (b)(4).

• 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 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11728462
• MDR Text Key: 261206533
• Report Number: 8030965-2021-03293
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2021
• 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
• Date Manufacturer Received: 04/10/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR
• Patient Weight: 85