MAUDE Adverse Event Report: SMITH & NEPHEW, INC. STRAIGHT CUT RASP; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	71935043
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Date of Event	09/15/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an arthroscopic guided latarjet procedure, after the abrasion of the glenoid neck using the straight reciprocating rasp, very thin metallic particles were observed in the intra-articular fluid.The procedure was finished using the same device, with no surgical delay and no injury to patient.
Event or Problem Description
It was reported that during an arthroscopic guided latarjet procedure, after the abrasion of the glenoid neck using the straight reciprocating rasp, very thin metallic particles were observed in the intra-articular fluid.Numerous small debris could not be removed from the patient.The procedure was finished using the same device, with no surgical delay and no injury to patient.
Additional Manufacturer Narrative
The device, used in treatment, was returned for evaluation.The clinical/medical team concluded, based on the product evaluation a user vs procedural event was the likely cause of the related event.The retained thin metallic particles from the straight reciprocating rasper are not implantable.Therefore, we are unable to rule out the possibility of local skin irritation, mri restrictions or micromotion and/or migration of the retained thin metallic particles.The future impact to the patient beyond the procedure and the retained thin metallic particles cannot be determined.Per report, the procedure completed using the same device, with no surgical delay or patient injury; therefore, no further clinical medical assessment is warranted at this time.A visual inspection confirmed scratches on the straight cut rasp.The device shows significant signs of wear/usage.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 products failed to meet any product specifications at the time of manufacture.A review of complaint history for the listed part revealed no prior complaints for the listed batch.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.This is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.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 warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: STRAIGHT CUT RASP
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10659388
• Report Number: 1020279-2020-05320
• Device Sequence Number: 2719772
• Product Code: HWE
• UDI-Device Identifier: 00885556645949
• UDI-Public: 00885556645949
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/18/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/24/2026
• Device Model Number: 71935043
• Device Catalogue Number: 71935043
• Device Lot Number: 16JTD0008B
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/15/2020
• Supplement Date Received by Manufacturer: 09/15/2020; 01/27/2021
• Initial Report FDA Received Date: 10/09/2020
• Supplement Report FDA Received Date: 10/12/2020; 02/18/2021
• 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: Required Intervention
• Patient Age: 19 YR
• Patient Weight: 73