MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INT HEX RC SCR BL 6.4X100; NAIL, FIXATION, BONE

Catalog Number 71642300

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Malposition of Device (2616)

Patient Problems Therapeutic Response, Decreased (2271); Non-union Bone Fracture (2369); No Code Available (3191)

Event Date 04/09/2017

Event Type  Injury  

Event Description

It was reported that post-operative hospital stay was extended to the patient and that she had to remain non-weight bearing for 6 weeks following trigen tan nail procedure, since at subsequent xray meeting it was noted that one of the 6.4mm screws was in the femoral head but not through the nail.

Manufacturer Narrative

(b)(4).

• Brand Name: INT HEX RC SCR BL 6.4X100
• 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 ; schachenallee 29; aarau 05001 ; SZ 05001
• MDR Report Key: 6593398
• MDR Text Key: 76013276
• Report Number: 1020279-2017-00369
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 03596010496959
• UDI-Public: 03596010496959
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K981529
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71642300
• Device Lot Number: 16AM09873
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2016
• 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; Required Intervention