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

Catalog Number	72202683
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/15/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the tweezers were used to pull the anchor, the wire tip broke.Tip was removed.A backup device was available to complete the procedure with no delay or patient injuries.
Additional Manufacturer Narrative
One 7209499 arthropierce 35 degree up angled instrument was reported on indicating instrument breakage.The complaint stated: ¿when using the tweezers to pull the anchor wire the tip broke.¿ the device was not returned for evaluation.Physical conclusions, full investigation and evaluation were not possible.Instrument tips may inadvertently be twisted or caught on other instruments or the basket during cleaning.This can lead to compromised strength.Final product met predetermined specifications upon release to distribution.

• 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: 8040025
• Report Number: 1219602-2018-01500
• Device Sequence Number: 13778573
• Product Code: LXH
• UDI-Device Identifier: 03596010651457
• UDI-Public: 03596010651457
• 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,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2018

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 Catalogue Number: 72202683
• Device Lot Number: 50523032
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/17/2018
• Supplement Date Received by Manufacturer: 11/30/2018
• Initial Report FDA Received Date: 11/05/2018
• Supplement Report FDA Received Date: 12/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR