MAUDE Adverse Event Report: SMITH & NEPHEW, INC. NAIL PROX DROP ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 71751131

Device Problem Connection Problem (2900)

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

Event Date 03/05/2021

Event Type  malfunction  

Event Description

It was reported that during an inspection in the warehouse it was noticed the failure of defective devices. It was noticed that the nail prox drop (b)(4) has a defective attachment. Three genesis ii tibial alignment spiked fixation rod (b)(4), the screwdriver release handle (b)(4), the journey ii bcs articular insert trial size 5-6 9mm right (b)(4), the journey ii bcs articular insert trial size 5-6 9mm left (b)(4), 0 deg 32 mm trial 48 mm (b)(4), the honeycomb (b)(4), the box chisel (b)(4), journey ii bcs articular insert trial size 1-2 11 mm right (b)(4) were noticed cracked. No case involved.

• Brand Name: NAIL PROX DROP
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116 ; UK 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 1450 brooks road; memphis, TN 38116 ; 5123913905
• MDR Report Key: 11593353
• Report Number: 1020279-2021-02488
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 03596010515438
• UDI-Public: 03596010515438
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K122170
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 08/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 71751131
• Device Catalogue Number: 71751131
• Device Lot Number: 17CCL0002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/13/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/30/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse