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

Model Number	71362294
Medical Device Problem Codes	Break (1069); Connection Problem (2900); Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample is under evaluation by manufacturing site.
Event or Problem 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.
Additional Manufacturer Narrative
H6: the associated device, intended for use in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The ratchet piece has broken off the handle, rendering it inoperable.The device shows signs of extensive use.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incidents.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: RATCHET HANDLE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12163720
• Report Number: 1020279-2021-05919
• Device Sequence Number: 17085969
• Product Code: HSB
• UDI-Device Identifier: 03596010454195
• UDI-Public: 03596010454195
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K122170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• 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
• Initial Date Received by Manufacturer: 07/07/2021
• Supplement Date Received by Manufacturer: 07/28/2021
• Initial Report FDA Received Date: 07/13/2021
• Supplement Report FDA Received Date: 07/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1