MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FREEDOM CLAMP 10.5MM TO 4MM; PIN, FIXATION, THREADED

Model Number	71064010
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/20/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery the clamps did not function.No delay was reported and the procedure was completed with a competitor device.
Additional Manufacturer Narrative
The devices, used in treatment, were returned for evaluation.A visual inspection of the returned devices did not reveal any obvious issues.The devices were manufactured in 2019.There was no wear and usage shown on the devices.A function evaluation was conducted and failure mode cannot be confirmed as both returned parts operate and function correctly and as intended.Both parts were produced this year and are from the same batch.Both clamp assemblies were re-checked functionally per ip 0014435 at final inspection.All gage checks passed inspection along with all function tests.Parts exhibit minimal signs of wear/usage.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 any manufacturing or material abnormalities that could have caused or contributed to the reported incident.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: FREEDOM CLAMP 10.5MM TO 4MM
• Common Device Name: PIN, FIXATION, THREADED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9344348
• Report Number: 1020279-2019-04080
• Device Sequence Number: 2157052
• Product Code: JDW
• UDI-Device Identifier: 03596010529046
• UDI-Public: 03596010529046
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K994143
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2020

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: 71064010
• Device Catalogue Number: 71064010
• Device Lot Number: 19EMS0317
• Initial Date Received by Manufacturer: 10/20/2019
• Supplement Date Received by Manufacturer: 04/13/2020
• Initial Report FDA Received Date: 11/19/2019
• Supplement Report FDA Received Date: 04/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1