MAUDE Adverse Event Report: SMITH & NEPHEW, INC. KNEE BALANCER SHAFT; PROSTH, KNEE, PATE/FEMOROTIBIAL, SEMI-CONST, UNCEM, PORO, COAT, POLY/METAL/POLY

Catalog Number	71933037
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/28/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a tka procedure, the connecting rod of the gap balancer can be connected to either the straight gap block or the connected buckling block, but the fault tool link cannot convert the two blocks.Unable to pull out.Delay of more than 2 hours reported.No confirmation of backup has been received.No impact or injury to patient reported.
Additional Manufacturer Narrative
The associated complaint device was not returned.A review of the provided pictures could not confirm the stated failure mode.A review of complaint history did not reveal additional complaints for the listed batch for the same failure mode.A review of the manufacturing records for the listed batch did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, the complaint can be re-opened.No further actions are being taken at this time.

• Brand Name: KNEE BALANCER SHAFT
• Common Device Name: PROSTH, KNEE, PATE/FEMOROTIBIAL, SEMI-CONST, UNCEM, PORO, COAT, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8626413
• Report Number: 1020279-2019-01989
• Device Sequence Number: 2049073
• Product Code: MBH
• UDI-Device Identifier: 03596010592071
• UDI-Public: 03596010592071
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K121393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2019

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: 71933037
• Device Lot Number: 17JCT0004
• Initial Date Received by Manufacturer: 04/28/2019
• Supplement Date Received by Manufacturer: 04/28/2019
• Initial Report FDA Received Date: 05/21/2019
• Supplement Report FDA Received Date: 10/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1