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

Catalog Number	71675511
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/11/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a delay occurred during the surgery because several guide pins were bent and had problems attaching to the nail.
Additional Manufacturer Narrative
It was noted that the hospital attributed this event to an user error.(b)(4).
Event or Problem 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
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 6984408
• Report Number: 1020279-2017-00935
• Device Sequence Number: 16314701
• Product Code: JDS
• UDI-Device Identifier: 00885556344248
• UDI-Public: 00885556344248
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K040212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2018

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: 71675511
• Device Lot Number: 17DM04350
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/12/2017
• Supplement Date Received by Manufacturer: 10/12/2017
• Initial Report FDA Received Date: 10/27/2017
• Supplement Report FDA Received Date: 02/21/2018
• 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: Other; Required Intervention