MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PCH SCSR STR; ACCESSORIES,ARTHROSCOPIC

Catalog Number	012036
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Foreign post code - (b)(6).
Event or Problem Description
It was reported that, during a biceps tenodesis surgery, the scissor punch clamp broke inside of the patient.All fragments were retrieved from the patient by using a grasper.A back-up device was used to complete the procedure within the scheduled time.The patient was not injured.
Additional Manufacturer Narrative
The reported straight scissor punch intended for use in treatment, was not returned for evaluation, however a photograph was supplied.Review of the photograph confirmed the reported complaint.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: excessive forces applied during use.The instruction for use were reviewed and were found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: PCH SCSR STR
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8786958
• Report Number: 1219602-2019-00804
• Device Sequence Number: 11184887
• Product Code: NBH
• UDI-Device Identifier: 03596010023728
• UDI-Public: 03596010023728
• 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): 08/09/2019

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: 012036
• Device Lot Number: 17379
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/24/2019
• Supplement Date Received by Manufacturer: 08/08/2019
• Initial Report FDA Received Date: 07/12/2019
• Supplement Report FDA Received Date: 08/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR