MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ORTHOMATCH UNIVERSAL CUT BLOCK; PRSTHSS, KNEE, PTLLFMRTBIAL, SM-CNSTRND, CMNTD, POLYMER/METAL/POLYMER

Catalog Number	71442109
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The associated orthomatch universal cutting block was not returned for evaluation.Without the return of the actual product involved and no batch information available, our investigation of this report is inconclusive.No additional actions are being taken at this time.However we will continue to monitor for future complaints and investigate further as necessary.We consider this investigation closed.Should additional information be received, the complaint will be reopened.Credit cannot be issued for the device.
Event or Problem Description
It was reported that the instrument was not holding firmly to 3' connector and it kept falling off increasing theatre time and causing inappropriate tibial cuts.Surgeon finished surgery using competitor's device.

• Brand Name: ORTHOMATCH UNIVERSAL CUT BLOCK
• Common Device Name: PRSTHSS, KNEE, PTLLFMRTBIAL, SM-CNSTRND, CMNTD, POLYMER/METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7712112
• Report Number: 1020279-2018-00881
• Device Sequence Number: 751594
• Product Code: JWH
• UDI-Device Identifier: 00885556494356
• UDI-Public: 00885556494356
• Combination Product (Y/N): N
• Initial Reporter Country: KE
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/22/2018

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2018
• Initial Report FDA Received Date: 07/23/2018
• 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