MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PCH BSKT DCKBL STR 1.5MM; ACCESSORIES,ARTHROSCOPIC

Catalog Number	012013
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during an arthroscopic surgery the device broke off, all the broken pieces were removed by the doctor.No patient injuries or delay reported.Back-up device was available to complete the surgery.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H6: the reported duckbill basket punch, intended for use in treatment, will not be returned for examination.However photographs were supplied.Examination of the photographs confirmed the reported breakage.The actuator has broken where it interfaces with the movable jaw, the movable jaw is free from the shaft.The cutting edges of the shaft appear to have been filed flat, this condition would require the use of excessive force to cut.The device appears to have been repaired in a manner inconsistent with current smith+nephew practices which contributed to the reported failure.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.Further investigation is not warranted at this time.E1: foreign zipcode (b)(6).

• Brand Name: PCH BSKT DCKBL STR 1.5MM
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9406237
• Report Number: 1219602-2019-01516
• Device Sequence Number: 14076353
• Product Code: NBH
• UDI-Device Identifier: 03596010023339
• UDI-Public: 03596010023339
• 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): 01/14/2020

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 Catalogue Number: 012013
• Device Lot Number: 50544033
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/13/2019
• Supplement Date Received by Manufacturer: 01/13/2020
• Initial Report FDA Received Date: 12/03/2019
• Supplement Report FDA Received Date: 01/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR