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

Model Number	7209161
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter foreign zip code: (b)(6).
Event or Problem Description
It was reported during the procedure the instrument was broken, all the pieces were removed from the patient.No patient injury was reported.
Additional Manufacturer Narrative
Additional information: visual inspection and functional testing could not be performed because the device in question was not returned for evaluation.Thus, the customer¿s complaint could not be verified, nor could a root cause be determined with confidence.A review of manufacturing records found no deviations or non-conformances during the manufacturing process.There are no indications to suggest the device did not meet product specifications upon release into distribution.
Additional Manufacturer Narrative
One 7209161 180 degree left bend cuff stitch product returned.The procedure was listed as: ¿shoulder instability¿.The device is four years old.The complaint indicated that the instrument was broken during the procedure and that all the pieces were removed from the patient.The device received is broken.Approximately ¼¿ of distal tip is missing.The 180 degree curved distal tip piece was not received although it is available for viewing in the customer¿s photo sent.The shaft is slightly bowed at the broken area.There are scratches from use.These are more prevalent at the distal tip.Per ifu: ¿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.No root cause related to the manufacture of the device was established.Use error may have been a contributing factor to the event.

• 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: 6975042
• Report Number: 1219602-2017-01330
• Device Sequence Number: 16254411
• Product Code: NBH
• UDI-Device Identifier: 03596010448927
• UDI-Public: (01)03596010448927(10)50523453
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/18/2018

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: 50523453
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2018
• Initial Date Received by Manufacturer: 10/24/2017
• Supplement Date Received by Manufacturer: 10/24/2017; 12/05/2017; 01/15/2018
• Initial Report FDA Received Date: 10/24/2017
• Supplement Report FDA Received Date: 11/25/2017; 12/07/2017; 01/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1