MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII ART INS SPCR TRL 1-2 {} 13MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	71430324
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/21/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while in surgery the instrument broke during the removal from the patient.All broken pieces were removed from the patient.There was no substantial procedural delay due to the breakage of the instrument.S+n back up was available if needed.
Additional Manufacturer Narrative
The associated device was returned and evaluated.A visual inspection confirms the spacer trial has a piece broken off.The broken piece was returned.The device also has multiple scratches, burr and gouges in the plastic.This device was manufactured in 2009.The device exhibits signs of significant use and wear.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.

• Brand Name: GII ART INS SPCR TRL 1-2 {} 13MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9475463
• Report Number: 1020279-2019-04411
• Device Sequence Number: 16792574
• Product Code: LXH
• UDI-Device Identifier: 03596010481412
• UDI-Public: 03596010481412
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/24/2019

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: 71430324
• Device Lot Number: 09KM03575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2019
• Initial Date Received by Manufacturer: 11/21/2019
• Supplement Date Received by Manufacturer: 12/18/2019
• Initial Report FDA Received Date: 12/16/2019
• Supplement Report FDA Received Date: 12/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1