MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CUFF STITCH 180 DEG LEFT; ACCESSORIES,ARTHROSCOPIC

Model Number	7209161
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/02/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery the point was broke.Procedure was completed with the same device.No delay, patient injuries or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The reported 180 degree left cuff stitch, intended for use in treatment, will not be returned for evaluation.Without the reported product a visual or functional evaluation cannot be performed and the customers complaint cannot be confirmed.From the information provided, the tip of the device broke.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: excessive force applied during use.The instruction for use was reviewed and was 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.
Additional Manufacturer Narrative
H10 h3,h6: the reported 180 degree cuff stitch left, used in treatment, has been returned for evaluation.Device is over thirteen years old.Visual assessment confirmed the reported breakage.The distal tip at beginning of first bend has been broken off.Broken section was returned for examination and shows evidence of plastic deformation to fracture at the break area.Examination of the break area of the shaft shows evidence of abnormal twisting/bend at fracture point.The condition of the device indicates it was subjected to excessive forces during use.The instruction for use outlines precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.A review of the manufacturing and complaint records was performed for the reported lot, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: CUFF STITCH 180 DEG LEFT
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9234196
• Report Number: 1219602-2019-01327
• Device Sequence Number: 16765035
• Product Code: NBH
• UDI-Device Identifier: 03596010448927
• UDI-Public: 03596010448927
• 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,Followup
• Report Date (Section B): 05/04/2020

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: 7209161
• Device Catalogue Number: 7209161
• Device Lot Number: 50184046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2020
• Initial Date Received by Manufacturer: 10/02/2019
• Supplement Date Received by Manufacturer: 11/17/2019; 04/29/2020
• Initial Report FDA Received Date: 10/24/2019
• Supplement Report FDA Received Date: 11/18/2019; 05/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 32 YR