MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ARTHROPIERCE XL, STRAIGHT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	72202683
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was cutting and breaking the sutures.No patient injury was reported.
Additional Manufacturer Narrative
Visual assessment using a stereo microscope confirmed the movable jaw has a sharp edge on one side.This condition could contribute to fraying and cutting of suture.A review of the complaint records confirmed this failure mode to be isolated in nature.This data indicates that sufficient controls (in-process and final inspections) are in place.No further action is warranted at this time.
Additional Manufacturer Narrative
Examination was not possible, as the device was not returned.The investigation could not draw any conclusions about the reported event without the return of the device.

• Brand Name: ARTHROPIERCE XL, STRAIGHT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7202563
• Report Number: 1219602-2018-00118
• Device Sequence Number: 13488600
• Product Code: LXH
• UDI-Device Identifier: 03596010651457
• UDI-Public: (01)03596010651457(10)50677354
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/07/2018

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: 72202683
• Device Catalogue Number: 72202683
• Device Lot Number: 50677354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2018
• Initial Date Received by Manufacturer: 01/03/2018
• Supplement Date Received by Manufacturer: 02/02/2018; 02/02/2018
• Initial Report FDA Received Date: 01/17/2018
• Supplement Report FDA Received Date: 02/07/2018; 03/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1