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

Model Number	7209161
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	05/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the tip of the suture instrument broke off in the joint.The broken tip was removed from the patient.A backup device was available t complete the procedure following a delay.No patient impact was reported.
Additional Manufacturer Narrative
Device investigation narrative - examination was not possible, as the device will not be returned.The investigation could not draw any conclusions about the reported event without the return of the device.Further investigation is not warranted at this time.Evaluation codes updated to indicate that manufacturing review was performed.(b)(4).
Additional Manufacturer Narrative
Two 180 degree cuff stitch left were returned for evaluation.Devices are over three years old.Visual assessment confirmed the reported breakage.The distal tips at the beginning of first bend have been broken off on each device.Broken sections were not returned for examination.The shafts on each device are bent.Examination of the break area shows evidence of abnormal twisting/bend.The condition of the devices indicates they were subjected to excessive forces during use.No root cause related to the manufacture of the device can be established.

• 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: 6612078
• Report Number: 1219602-2017-00584
• Device Sequence Number: 13625044
• Product Code: NBH
• UDI-Device Identifier: 03596010448927
• UDI-Public: (01)03596010448927(10)50523453
• 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: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/07/2018

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: 01/24/2018
• Initial Date Received by Manufacturer: 05/15/2017
• Supplement Date Received by Manufacturer: Not provided; 02/05/2018
• Initial Report FDA Received Date: 06/05/2017
• Supplement Report FDA Received Date: 06/07/2017; 02/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1