MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CLASSIC CHS PL 3 SLOT 130 DEG; APPLIANCE, FIXATION, NAILBLADEPLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number	124125
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/28/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to a patient fall and broken implant.
Additional Manufacturer Narrative
The associated devices were returned and evaluated.The lab analysis concluded that the visual inspection did not show a fracture of the implant.No other deviations were identified during this investigation.The medical investigation concluded that the x-ray provided do not provide an indication for the root cause of the reported fall but non-union of the previous repair cannot be ruled out.Based on the information provided the revision surgery was performed due to a fall injury that was sustained by the patient and not a mal-performance of the implant.The impact to the patient beyond the revision cannot be concluded.Should additional information becomes available this issue can be re-elevated.No further clinical assessment is warranted at this time.A review of complaint history did not reveal additional complaints for the listed batches.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: CLASSIC CHS PL 3 SLOT 130 DEG
• Common Device Name: APPLIANCE, FIXATION, NAILBLADEPLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9112789
• Report Number: 1020279-2019-03466
• Device Sequence Number: 14393397
• Product Code: KTT
• UDI-Device Identifier: 03596010072856
• UDI-Public: 03596010072856
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K993289
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 124125
• Device Lot Number: 18ET03927
• Initial Date Received by Manufacturer: 08/28/2019
• Supplement Date Received by Manufacturer: 12/12/2019
• Initial Report FDA Received Date: 09/24/2019
• Supplement Report FDA Received Date: 12/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 74 YR