MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RATCHET HANDLE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 71362294

Device Problems Break (1069); Connection Problem (2900); Naturally Worn (2988)

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

Event Date 06/17/2021

Event Type  malfunction  

Manufacturer Narrative

The sample is under evaluation by manufacturing site.

Event Description

It was reported that, during the set up of a thr surgery, a reflection ratchet handle was not able to capture because it is worn due to excessive use. Surgery was performed, without any delay, using a back-up device. Patient was not injured as consequence of this problem. However, the investigation found that a piece has broken off the handle, which makes this event a reportable malfunction. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.

• Brand Name: RATCHET HANDLE
• 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: 12163720
• MDR Text Key: 261461109
• Report Number: 1020279-2021-05919
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 07/28/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 07/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 71362294
• Device Catalogue Number: 71362294
• Device Lot Number: 14MM19264
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2021
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown