MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BLADE,4.5 BONECUTTER,FR,180MM LG,DSP; SAW, POWERED, AND ACCESSORIES

Catalog Number	7210979
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during a hip arthroscopy, the shaver blade loosed parts and broke inside the patient.It was received additional information stating that this happened in the 4th time, not in 4 different cases.The pieces were removed from the patient and there was no delay or patient injuries reported but it is unknown if a backup was available to complete the procedure.Attempts were made to retrieve further details about the event but the complainant does not have more information.
Additional Manufacturer Narrative
H10: h3,h6: one 4.5mm x180mm long platinum full radius bonecutter was returned for evaluation.Visual assessment of the device showed the polycarbonate of the adapter body is cracked where the outer blade interfaces.Removal of the inner blade from the outer blade showed delamination of the plating at the tip of the inner blade.Based on the investigation that was performed, there was some slight discoloration noted on several portions of the inner blade tip; no surface issues were noted beyond the tip/tube weld location.During the functional spin test, there was no friction felt; the inner blade rotated freely within the outer blade in the unloaded condition.Visual assessment confirmed that the inner blade exhibited circular abrasion marks in/around the cutting window along with corresponding abrasions on the outer blade (i.D.).These abrasions appear to have been created from the inner edgeform cutting surface(s) making contact with the id of the outer edgeform during use.This condition is prevalent when excessive side loading on the blade occurs during use.There were substantial tissue remains inside the tip cutting surfaces and the adapter body exhibited a crack where it mates with the outer tube; the sluff chamber showed no signs of damage.The discoloration areas on the tip appeared to be minor delamination of plating when reviewed under magnification.In this instance, the plating delamination that was noted on the inner tip along with the cracked adapter body is a result from surface contact that is made between the inner/outer blade components during use when excessive side load force occurs, thus creating a shed/flake condition.The investigation has confirmed this complaint finding where a shedding/flaking issue occurred on the device as described by the customer.Per the investigation, it appears that there was excessive side loading on the device during use which resulted in a shed/flaking issue.Due to the low frequency of occurrence and the biological safety of materials of manufacture, this failure mode will continue to be monitored as required.Per instructions for use; excessive ¿side-loading¿ on the blade during use does not improve cutting performance, and in extreme cases may result in wear and degradation of the inner blade.Based on the product evaluation, excessive side loading during use resulted in a shed/flaking issue.The instruction for use does caution against inner blade wear due to excessive side loading.No further patient impact is anticipated as no delay, patient injury, or foreign body was reported.A review of the complaint and manufacturing records was performed and there were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: BLADE,4.5 BONECUTTER,FR,180MM LG,DSP
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9142703
• Report Number: 1219602-2019-01192
• Device Sequence Number: 3046909
• Product Code: HAB
• UDI-Device Identifier: 03596010544001
• UDI-Public: 03596010544001
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2020

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: 09/07/2021
• Device Catalogue Number: 7210979
• Device Lot Number: 50792052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2019
• Initial Date Received by Manufacturer: 09/09/2019
• Supplement Date Received by Manufacturer: 01/06/2020
• Initial Report FDA Received Date: 10/01/2019
• Supplement Report FDA Received Date: 01/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 38 YR