MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ORTHOMATCH UNIVERSAL CUT BLOCK; PRSTHSIS,KNEE,PATLLOFMOROTIBIAL,SMI-CNSTRAIND,CMNTD,POLYMR/MTAL/POLYMR

Catalog Number	71442109
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/20/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the device didn't attach firmly to the tibial 3¿ connector, when cutting the proximal tibial cuts the cuts were not horizontal, when the surgeon put the trial tibial implant and insert, the patella was not tracking well, upon rechecking on the cuts, it was noticed the cut wasn¿t parallel due to loosening of the block.
Additional Manufacturer Narrative
The associated complaint device was not returned.The clinical/medical team concluded, insufficient documentation was provided, therefore a thorough medical investigation cannot be performed.No further medical assessment is warranted at this time.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.

• Brand Name: ORTHOMATCH UNIVERSAL CUT BLOCK
• Common Device Name: PRSTHSIS,KNEE,PATLLOFMOROTIBIAL,SMI-CNSTRAIND,CMNTD,POLYMR/MTAL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7585363
• Report Number: 1020279-2018-01087
• Device Sequence Number: 1422805
• Product Code: JWH
• UDI-Device Identifier: 00885556494356
• UDI-Public: 00885556494356
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K142807
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 71442109
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2018
• Supplement Date Received by Manufacturer: 05/20/2018
• Initial Report FDA Received Date: 06/09/2018
• Supplement Report FDA Received Date: 08/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other