MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC ROD,FIXATION,INTRAMEDULLARY

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Discomfort (2330); Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

If the information is unknown, not available or does not apply. Patient information was not provided for reporting. Date of event is unknown. This report is for unknown quantity of unknown titanium flexible intramedullary nails. Part#, lot# and udi # is not available. Implant/explant date: unknown. Device is not expected to be returned for manufacturer review/investigation. This report is for unknown quantity of unknown titanium flexible intramedullary nails. Pma/510(k) number is not available. Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer. Additionally, device history records review could not be completed without lot number. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. (b)(4).

Event Description

This report is being filed after the review of the following journal article: sink, el. , gralla, j. And repine, m. (2005), complications of pediatric femur fractures treated with titanium elastic nails a comparison of fracture types, journal of pediatric orthopedic, vol. 25 no. 5, pages 577-580 (united states of america). The purpose of this retrospective study is to review complications seen with titanium elastic nail (tens) and to recognize factors that increase the risk of complications as it relates to the nature of the fracture. Between january 2001 and january 2003, a total of 39 patients with femur fractures were treated with unknown synthes titanium intramedullary nails. Of these patients, 24 patients were treated for length stable fractures and 15 patients for length-unstable fractures. Mean follow-up was 11 months (range; 3-29 months). The following complications were reported as follows: an (b)(6) patient underwent an unplanned surgery for prominent and exposed nail shortening. Thirteen patients reported pain around the knee incisions and nail ends that often-inhibited full range of knee motion. Eleven patients were noted to have prominent palpable nails on examination. Two patients had postoperative wound infections after elective hardware removal that was successfully treated with antibiotics. One patient had nonunion, a 20-degree procurvatum without any obvious clinical deformity or functional deficit. One case of delayed union (>6 months) that healed without intervention in a patient with comminuted midshaft fracture who needed the fracture site exposed to pass the nails. Two patients had transverse fractures. One developed thigh compartment syndrome requiring fasciotomy and plating. The other patient was stabilized with two 4. 0-mm nails placed in the canal with the convex contour of the rod directed in the same plane, causing an early angulation of 16 degrees and necessitating application of an external fixator the following day. Twelve patients with stable transverse fractures had unknown complications, and 2 of the 12 patients underwent surgery for their complication. Twelve patients with unstable fractures had unknown complication and 6 of the 12 patients underwent surgery to address the complication. Ten patients in the unstable fracture group had either fracture shortening or angulation. Three patients in the transverse fracture group had either fracture shortening or angulation. Six patients underwent procedures to shorten or remove extremely prominent or exposed nails around the knee. All these patients had either long oblique or comminuted length-unstable fractures. As the fractures shortened or angulated in the early postoperative period, the nails migrated distally, becoming prominent or exposed. This report is for unknown quantity of unknown titanium flexible intramedullary nails. This is report 2 of 3 for (b)(4). A copy of the literature article is being submitted with this medwatch.

• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7925491
• MDR Text Key: 122310921
• Report Number: 2939274-2018-54046
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 10/02/2018 Patient Sequence Number: 1