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	08/21/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery the spacer broke when it was being snapped to the other instrument.No delay was reported and a backup device was available.The device broke over the patient´s incision but all the pieces were recovered.
Additional Manufacturer Narrative
The associated complaint device was not returned.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.

• 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: 9068737
• Report Number: 1020279-2019-03366
• Device Sequence Number: 11388707
• Product Code: LXH
• UDI-Device Identifier: 03596010481412
• UDI-Public: 03596010481412
• Combination Product (Y/N): N
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2019

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
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/21/2019
• Supplement Date Received by Manufacturer: 10/30/2019
• Initial Report FDA Received Date: 09/16/2019
• Supplement Report FDA Received Date: 11/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1