MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 11.5MM X 18CM 125D; NAIL, FIXATION, BONE

Catalog Number	71675202
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/30/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery the drill interfered with the nail, the distal screw could not be hold into place, resulting in using other length screw.Procedure was completed free hands.Delay from (0 - 30) minutes reported.Backup device available.No injury or impact to patient reported.
Additional Manufacturer Narrative
The associated complaint device was not returned.A review of the production documentation for the corresponding products 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 batch.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: INTERTAN 11.5MM X 18CM 125D
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8364847
• Report Number: 1020279-2019-00778
• Device Sequence Number: 2126722
• Product Code: JDS
• UDI-Device Identifier: 03596010561053
• UDI-Public: 03596010561053
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K040212
• 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): 06/08/2019

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: 71675202
• Device Lot Number: 18GT06637
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/31/2019
• Supplement Date Received by Manufacturer: 06/06/2019
• Initial Report FDA Received Date: 02/24/2019
• Supplement Report FDA Received Date: 06/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1