MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII NON SPIKE-FIXATION ROD; PROST, KNEE, PAT/FEMTIB, SEMI-CONSTRAIN, UNCEMENT, POROUS, COAT, POLY/MET/POLY

Model Number	71440446
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/02/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, the two instruments won't come apart for cleaning.It caused a delay of 30 minutes to an hour.There was an s&n backup device available.No patient injuries were reported.
Additional Manufacturer Narrative
The devices used in treatment were returned and evaluated.A visual inspection of the returned devices confirms that the devices got stuck to each other.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A complaint history review found related failures; this failure mode will be trended by post market surveillance to assess for any necessary corrective actions.These devices are reusable instruments that can be exposed to numerous surgeries; damage from repeated use can occur.Probable causes that could contribute to the reported event, as reusable instruments are susceptible to missing components, damage from prolonged use and through misuse or rough handling.To avoid compromised performance or damage, it is recommended the devices be inspected prior to and after each use and cleaning.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 NON SPIKE-FIXATION ROD
• Common Device Name: PROST, KNEE, PAT/FEMTIB, SEMI-CONSTRAIN, UNCEMENT, POROUS, COAT, POLY/MET/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9610470
• Report Number: 1020279-2020-00348
• Device Sequence Number: 18969493
• Product Code: MBH
• UDI-Device Identifier: 03596010215567
• UDI-Public: 03596010215567
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2020

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: 71440446
• Device Catalogue Number: 71440446
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Initial Date Received by Manufacturer: 01/02/2020
• Supplement Date Received by Manufacturer: 02/18/2020
• Initial Report FDA Received Date: 01/21/2020
• Supplement Report FDA Received Date: 02/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1