MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HFN 10MMX16CM RIGHT; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	71701016R
Medical Device Problem Codes	Connection Problem (2900); Device Handling Problem (3265)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/10/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a malfunction occurred during surgery.The hfn nail, out of 5 screws only 3 screws were going through the jig.Remaining 2 screws went out of the nail when surgeon tried this in case.At the same time when surgeon loaded the nail on jig the drill bit went through the holes but not on table when it was used with patient.There was a delay of 1 hour since there was no back up available.Surgeon used the traditional technique she put free hand screws without jig.There was no affectation or injury to patient.
Additional Manufacturer Narrative
The affected trigen hindfoot fusion nail was not returned for evaluation.The device was manufactured in 2017.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.Without the return of the actual product involved, our investigation of this report is inconclusive.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: HFN 10MMX16CM RIGHT
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8101222
• Report Number: 1020279-2018-02575
• Device Sequence Number: 16408475
• Product Code: HSB
• UDI-Device Identifier: 03596010543134
• UDI-Public: 03596010543134
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K043052
• 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): 02/05/2019

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: 71701016R
• Device Lot Number: 17GM10252
• Initial Date Received by Manufacturer: 11/01/2018
• Supplement Date Received by Manufacturer: 11/01/2018
• Initial Report FDA Received Date: 11/26/2018
• Supplement Report FDA Received Date: 02/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1