MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ARTHROSCOPE 2.7 X 70DEG X

Model Number	3948
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the distal lens of the scope were broken.No case reported; therefore, there was no patient involvement.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 device, which was not used in a procedure, was returned for evaluation.There was a relationship between the reported event and the device.A visual inspection was performed and showed the scope to have distal tip and fiber damage, a bent outertube and a scratched negative lens.A review of the manufacturing records found that there was no evidence that the product didn¿t meet specifications at the time of manufacture.A complaint history review found related failures; this failure mode will be trended to assess for any necessary corrective actions.This failure is confirmed not originate from manufacturing, packaging, or labeling defects.This damage is caused by contact with another source.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.No manufacturing related defects were observed.
Additional Manufacturer Narrative
H10.H3, h6: the device, which was not used in a procedure, was not returned for evaluation.Visual inspection and functional testing could not be performed.A relationship, if any, between the device and the reported incident could not be confirmed.A review of the manufacturing records found that there was no evidence that the product didn¿t meet specifications at the time of manufacture.Factors that are known to contribute to the alleged fault/failure may include mishandling during shipping, use or reuse of the device, contact with another source, or wear and tear over time.If the product is returned in the future the complaint can be reopened and evaluated.No further investigation is required.

• Brand Name: ARTHROSCOPE 2.7 X 70DEG X
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 10544400
• Report Number: 3003604053-2020-00106
• Device Sequence Number: 19150082
• Product Code: HRX
• UDI-Device Identifier: 03596010121028
• UDI-Public: 03596010121028
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K971253
• 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,Followup
• Report Date (Section B): 10/20/2020

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 Model Number: 3948
• Device Catalogue Number: 3948
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Initial Date Received by Manufacturer: 08/24/2020
• Supplement Date Received by Manufacturer: 10/06/2020; 10/19/2020
• Initial Report FDA Received Date: 09/16/2020
• Supplement Report FDA Received Date: 10/08/2020; 10/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1