MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 1.5 11.5MMX32CM 130D RT; NAIL, FIXATION, BONE

Catalog Number	71676574
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/01/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery the intertan nail got stuck to the handle.Delay of over 2 hours reported.No injury reported.Procedure finished with competitor device.
Additional Manufacturer Narrative
The associated drill guide handle and the nail were returned and evaluated.A visual inspection found that the nail is fixed on the drill guide; the devices cannot be separated.It is possible that the threads on both devices were cross threaded causing them to fail.A review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.Our investigation did not determine a specific cause of the stated failure.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.We consider this investigation closed.

• Brand Name: INTERTAN 1.5 11.5MMX32CM 130D RT
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8106036
• Report Number: 1020279-2018-02600
• Device Sequence Number: 2026486
• Product Code: JDS
• UDI-Device Identifier: 00885556039250
• UDI-Public: 00885556039250
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K040212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2019

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 Expiration Date: 10/14/2021
• Device Catalogue Number: 71676574
• Device Lot Number: 11KM08454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2018
• Initial Date Received by Manufacturer: 11/02/2018
• Supplement Date Received by Manufacturer: 11/02/2018
• Initial Report FDA Received Date: 11/27/2018
• Supplement Report FDA Received Date: 01/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1