MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS GMBH INT HEX CAP SCREW 4.5MM X 35MM; TITANIUM NAIL SYSTEM

Catalog Number 71642135

Device Problems Difficult to Insert (1316); Device Markings/Labelling Problem (2911)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/17/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that an adolescent femoral nail surgery was delayed over 1 hour because the distal screw would not insert correctly.The surgeon states the screw was 5.0mm while the label states it was 4.5mm.The surgeon finished the surgery with a different screw.

• Brand Name: INT HEX CAP SCREW 4.5MM X 35MM
• Type of Device: TITANIUM NAIL SYSTEM
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS GMBH; gaensaecker 27; tuttlingen 78532 ; GM 78532
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS GMBH; gaensaecker 27; tuttlingen 78532 ; GM 78532
• Manufacturer Contact: robert rust ; 1450 brooks road; memphis, TN 38116 ; 9013991624
• MDR Report Key: 5272977
• MDR Text Key: 32860524
• Report Number: 8010764-2015-00055
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K981529
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/13/2023
• Device Catalogue Number: 71642135
• Device Lot Number: 13HT33660
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2013
• 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): Hospitalization
• Patient Age: 14 YR
• Patient Weight: 55