MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN TRIGEN INTERTAN INTERTROCH ANTEGR NAIL INSTR; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number UNKNOWN

Device Problems Fracture (1260); Separation Failure (2547)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/31/2024

Event Type  malfunction  

Event Description

It was reported that during an internal fixation removal, using a meta-tan lag/comp kit 95/90, the screw was stuck too tightly to be removed, causing the tool to break.It was finally removed via a broken nail remover.It is unknown how was completed the procedure and if a delay was presented.No injury to patient was reported.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

Manufacturer Narrative

B5: describe event or problem, d1: brand name, d4: catalog number, lot#, udi di#, h6: health effect - impact code and medical device problem code.

Event Description

It was reported that during an internal fixation removal surgery, the nail removal tool (unkn trigen intertan intertroch antegr nail instr (b)(4)) broke when it was used to removed the meta-tan lag/comp kit 95/90 ((b)(4)), the screw was stuck too tightly to be removed.It was finally removed via a broken nail remover.The procedure was resumed, with the same device, after a significant delay.No injury to the patient was reported.

• Brand Name: UNKN TRIGEN INTERTAN INTERTROCH ANTEGR NAIL INSTR
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 18744234
• MDR Text Key: 335952535
• Report Number: 1020279-2024-00412
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K092748
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/13/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1