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

Catalog Number	7209161
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during the surgical procedure, when the suture technique was performed, the forceps broke inside the patient.The pieces had been removed from the patient.There was a back up device available and no patient injury or other complications were reported.
Additional Manufacturer Narrative
The reported 180 degree cuff stitch left has not been returned for examination.Without the reported product a visual evaluation cannot be performed and the customers complaint cannot be confirmed.From the information provided, the tip broke during use from the inserter.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: application of excessive force 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
The reported 180 degree cuff stitch left intended for use in treatment, has been returned for evaluation.Visual assessment of the device confirmed the reported breakage.The distal tip has broken off of the shaft and was not returned for examination.The shaft is also bent.The break area shows no material voids , however it does show evidence of plastic deformation.The condition of the device indicates it was subjected to excessive forces during use.Per the device instructions for use as with any surgical instrument, careful attention should be exercised to ensure that excessive force is not placed on the instrument.Excessive force can result in instrument failure.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: 9109453
• Report Number: 1219602-2019-01162
• Device Sequence Number: 3762130
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/28/2019

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: 7209161
• Device Lot Number: 50523454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2019
• Initial Date Received by Manufacturer: 09/02/2019
• Supplement Date Received by Manufacturer: 10/18/2019; 10/25/2019
• Initial Report FDA Received Date: 09/24/2019
• Supplement Report FDA Received Date: 10/21/2019; 10/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR