MAUDE Adverse Event Report: ZIMMER, INC. NATURAL NAIL ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 47-2495-340-09

Device Problems Break (1069); Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 07/12/2021

Event Type  malfunction  

Event Description

Narrative from staff: patient underwent a right tibial shaft fracture im nailing. Patient was seen in outpatient clinic, as patient was having increased pain in the distal leg. X-rays revealed a broken intramedullary nail just at the level of the most proximal locking screws. Patient also had some deformity. Surgeon recommended that the nail be revised with a new nail to correct the deformity. Patient underwent removal of implant and exchange nailing. Manufacturer response for rod, fixation, intramedullary and accessories, natural nail® (per site reporter): device provided to representative after case. Manufacturer response for rod, fixation, intramedullary and accessories, natural nail® (per site reporter): device provided to representative after case. Manufacturer response for rod, fixation, intramedullary and accessories, natural nail® (per site reporter): device provided to representative after case. Manufacturer response for rod, fixation, intramedullary and accessories, natural nail® (per site reporter): device provided to representative after case. Manufacturer response for rod, fixation, intramedullary and accessories, natural nail® (per site reporter): device provided to representative after case.

• Brand Name: NATURAL NAIL
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): ZIMMER, INC.; 56 east bell drive; warsaw IN 46581
• MDR Report Key: 12459404
• MDR Text Key: 271011203
• Report Number: 12459404
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/09/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 09/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 47-2495-340-09
• Device Catalogue Number: 47-2495-340-09
• Device Lot Number: 64941866
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/09/2021
• Event Location: Other
• Date Report to Manufacturer: 09/13/2021
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown