MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ABRADER,5.5,EP-1,DSPL BLADE; SAW, POWERED, AND ACCESSORIES

Model Number	7205325
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during the procedure, while the blade was being used in the patient, plastic shavings of the connector fell off into the joint.The plastic shavings were tried to be removed by forceps, but could not completely be taken out from the patient.It is unknown if there was a surgical delay.The procedure was completed with the same device and no patient injuries were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6: the reported 5.5mm abrader burr, intended for use in treatment, was returned for evaluation.Visual assessment of the burr confirmed the reported complaint.A small piece of the polycarbonate sluff chamber has come free.The polycarbonate components the sluff chamber and adapter body are in the early stages of melting.The condition of the device indicate little to no irrigation was used to cool the blade during its operation.Per the device instructions for use under warnings ¿periodic irrigation of the blade is recommended to provide adequate cooling of the blade and to prevent accumulation of excised materials in the surgical site.Ensure that suction of 128 mmhg minimum is flowing while the instrument is running¿.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.Further investigation is not warranted at this time.Reportedly while using the abrader burr blade plastic shavings of the connector fell off into the patient¿s joint.It was communicated that the plastic shavings were not completely retrieved using forceps.It is unknown if there was a delay.The procedure was completed with the same device and with no patient injuries.No clinically relevant supporting documentation was provided for inclusion in this medical investigation.The 5.5mm abrader burr was returned for analysis and the visual assessment revealed that ¿the polycarbonate components the sluff chamber and adapter body are in the early stages of melting¿ and ¿the condition of the device indicate little to no irrigation was used to cool the blade during its operation.¿ the material of the retained shavings: polycarbonate is an amorphous thermoplastic with high impact strength, dimensional stability, thermal resistance, low-temperature toughness, and has high transparency.Conclusion: based on the results of the product evaluation the root cause for the reported plastic shavings was a user vs procedural event due to little or no irrigation being used to cool the blade during its operation.Per the device instructions for use under warnings ¿periodic irrigation of the blade is recommended to provide adequate cooling of the blade and to prevent accumulation of excised materials in the surgical site.Biocompatibility for polycarbonate is well characterized for prolonged (up to ~1 month) tissue contact.The patient impact beyond possible micro-motion and/or migration and local irritation/discomfort cannot be determined.No further medical assessment can be rendered at this time.

• Brand Name: ABRADER,5.5,EP-1,DSPL BLADE
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9390505
• Report Number: 1219602-2019-01505
• Device Sequence Number: 11532545
• Product Code: HAB
• UDI-Device Identifier: 03596010251534
• UDI-Public: 03596010251534
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2020

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 Expiration Date: 01/06/2024
• Device Model Number: 7205325
• Device Catalogue Number: 7205325
• Device Lot Number: 50779783
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2019
• Initial Date Received by Manufacturer: 11/07/2019
• Supplement Date Received by Manufacturer: 01/27/2020
• Initial Report FDA Received Date: 11/28/2019
• Supplement Report FDA Received Date: 01/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1