MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 10S 10MM X 36CM 125D LEFT; NAIL, FIXATION, BONE

Catalog Number 71675511

Device Problem Failure to Align (2522)

Patient Problem Injury (2348)

Event Date 10/11/2017

Event Type  Injury  

Event Description

It was reported that a delay occurred during the surgery because several guide pins were bent and had problems attaching to the nail.

Manufacturer Narrative

It was noted that the hospital attributed this event to an user error.(b)(4).

Event Description

It was reported that when inserting the anti rotation bar into the femoral head the operators noticed it converged with the 3.2mm x 343mm guide pin.They tried a new guide pin as they discovered it was bent, only to have the same result.When they removed the new one it was bent too.They removed the whole nail and noticed the set screw had dropped possibly bending the guide pin on entry.They were not sure why the set screw had dropped but there was some feeling the 4.7mm hex had been incorrectly used to try to attach the nail to the jig.Surgical delay occured due to this but to no adverse outcome to the patient.

• Brand Name: INTERTAN 10S 10MM X 36CM 125D LEFT
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: markus poettker ; 1450 brooks road; memphis, TN 38116
• MDR Report Key: 6984408
• MDR Text Key: 90456879
• Report Number: 1020279-2017-00935
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 00885556344248
• UDI-Public: 00885556344248
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K040212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71675511
• Device Lot Number: 17DM04350
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/06/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention