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	03/11/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery the instrument broke.No delay was reported and a backup device was available.Piece fall inside the patient and was recovered.
Additional Manufacturer Narrative
The affected genesis ii articular insert spacer trial was not returned for evaluation.Therefore a product analysis could not be performed.After repeated requests, smith and nephew has been unable to obtain device details.Complaint history review could not be performed with any accuracy due to lack of batch information.Smith and nephew has an outstanding request with the reporter for information.The spacer trial is a reusable device that can be exposed to numerous surgeries; damage from repeated use can occur.Several potential factors that could contribute to the reported event, as reusable instruments are susceptible to damage from prolonged use and through misuse or rough handling.To avoid compromised performance or damage, it is recommended the device be inspected prior to/after each use and cleaning.Without the return of the actual product involved and no batch information available, our investigation of this report is inconclusive.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: 8468289
• Report Number: 1020279-2019-01300
• Device Sequence Number: 16398718
• 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): 06/23/2019

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
• Initial Date Received by Manufacturer: 03/11/2019
• Supplement Date Received by Manufacturer: 06/20/2019
• Initial Report FDA Received Date: 04/01/2019
• Supplement Report FDA Received Date: 06/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1