MAUDE Adverse Event Report: SYNTHES GMBH UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE; ROD, FIXATION, INTRAMEDULLARY

Device Problem Migration (4003)

Patient Problem Unspecified Infection (1930)

Event Date 10/29/2021

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown nail head elements: tfna helical blade/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.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.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 the patient underwent a tfna procedure with the implants in question on an unknown date.Postoperatively, the patient had a suspected surgical site infection.It was seen on x-rays that the tfna screw had become disengaged from the locking mechanism.On (b)(6) 2021, the surgeon further advanced the internal locking mechanism in order to re-lock the screw.There was a surgical delay of greater than thirty (30) minutes.It was stated that during the initial implant surgery that the screw was too short and advanced further than the surgical technique states it should be positioned.This report is for one (1) unk nail head elements: tfna helical blade.This is report 1 of 3 for (b)(4).

Manufacturer Narrative

This report is for an unknown nail head elements: tfna helical blade/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.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.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 the patient underwent a tfna procedure with the implants in question on an unknown date.Postoperatively, the patient had a suspected surgical site infection.It was seen on x-rays that the tfna screw had become disengaged from the locking mechanism.On (b)(6) 2021, the surgeon further advanced the internal locking mechanism in order to re-lock the screw.There was a surgical delay of greater than thirty (30) minutes.It was stated that during the initial implant surgery that the screw was too short and advanced further than the surgical technique states it should be positioned.This report is for one (1) unk nail head elements: tfna helical blade.This is report 1 of 3 for (b)(4).

• Brand Name: UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE
• 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: 12838222
• MDR Text Key: 285985723
• Report Number: 8030965-2021-09637
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 10/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2021
• 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: 10/29/2021
• 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
• Treatment: UNK - NAILS: TFNA.; UNK - SCREWS: NAIL DISTAL LOCKING.
• Patient Outcome(s): Required Intervention