MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CANNULATED REAMER 4.8MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	110069
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/18/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery the screw driver in the set was broken (the tip hex part was not there).There was no cannulated drill bit in the set.These are two essential instruments for the insertion of these screws, the tap was used to break the cortex, the screw was turned in by hand half way, where the guide pin had to be removed and then inserted all the way.Structure was also booked (b)(4) but mixing these was difficult and did not work well even though instructions was followed.The surgeon had to revert to open surgery as he needed to insert the bone graft (the patients was counseled for arthroscopic surgery as well as consented, not open).Increased risk of infection due to bone graft being inserted by hand.Less than 30 minutes delay was reported.The patient is now septic and had to be taken back to surgery for a debridement.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A clinical evaluation was conducted and although it was reported that the patient was septic no documents were provided for review.As a result of converting to an open procedure, the complaint indicates approximately 19 days after the initial procedure this patient developed sepsis and underwent a debridement and vac therapy was provided.However, without the requested labs, supporting clinical documents or records of antibiotic therapy the root cause of the reported infection cannot be confirmed.The current status of the patient is unknown due to the limited information provided.Should any additional clinical information be provided this complaint will be re-assessed.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.

• Brand Name: CANNULATED REAMER 4.8MM
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8791756
• Report Number: 1020279-2019-02688
• Device Sequence Number: 2102927
• Product Code: JWH
• UDI-Device Identifier: 03596010033635
• UDI-Public: 03596010033635
• 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): 10/31/2019

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: 110069
• Initial Date Received by Manufacturer: 06/18/2019
• Supplement Date Received by Manufacturer: 06/18/2019
• Initial Report FDA Received Date: 07/15/2019
• Supplement Report FDA Received Date: 10/31/2019
• 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: Hospitalization; Required Intervention