MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HEWSON SUTURE RETRIEVER; RETENTION DEVICE, SUTURE

Catalog Number	71111579
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/21/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a partial patellectomy with patellar tendon advancement for patella fracture a smith & nephew hewson suture retriever was being used when a piece of the passer loop broke off and was unable to be retrieved.
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.It was reported that a piece of the passer loop from the hewson suture retriever broke off and was unable to be retrieved, and remains in the patient.It has been requested to identify the exact piece of the device that is retained, as there are different material compositions for each component of the device.Therefore, without knowing what portion remains in the patient at this time, the material composition/biocompatibility cannot be determined at this time.Additional communication states that the patient has exhibited no adverse symptoms to this date, and the need for revision surgery has not been indicated.The future impact to the patient cannot be determined.No further clinical assessment can be performed.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal any material or manufacturing deviations 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.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: HEWSON SUTURE RETRIEVER
• Common Device Name: RETENTION DEVICE, SUTURE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 6869245
• Report Number: 1020279-2017-00750
• Device Sequence Number: 1443480
• Product Code: KGS
• UDI-Device Identifier: 03596010510495
• UDI-Public: 03596010510495
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2018

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: Hospital Service Technician
• Device Catalogue Number: 71111579
• Device Lot Number: 17CSM0077
• Initial Date Received by Manufacturer: 09/13/2017
• Supplement Date Received by Manufacturer: 09/13/2017
• Initial Report FDA Received Date: 09/15/2017
• Supplement Report FDA Received Date: 04/24/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other