MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - SCREWS: LAG; SCREW,FIXATION,BONE

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Code Available (3191)

Event Date 09/01/2005

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.(b)(4).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: freedman d., kono m., johnson e.,(2005) pathologic patellar fracture at the site of an old sinding-larsen johansson lesion a case report of a (b)(6)-year-old male, journal of orthopaedic trauma volume 19 no.8, pages 582¿585 (usa) doi: 10.1097/01.Bot.0000151817.55551.2d.This study presents a case report of a male patient who sustained a pathologic fracture, incurred with minimal trauma, through a fibrous union at the site of an old sinding-larsen-johansson (slj) lesion.A case of a (b)(6)-year-old student with no systemic illness and no previous history of knee pain or trauma during childhood or adulthood.He lost his footing while walking downstairs, causing him to catch his body weight on his right lower extremity.He had an immediate painful giving way of his right knee associated with an audible pop, followed by an inability to bear weight.An evaluation revealed a large effusion, palpable defect, painful passive range of motion, and inability to extend his knee against gravity.Radiographs demonstrated a displaced inferior pole patellar fracture with rounding and sclerosis at the fracture site of an old slj lesion.In addition, there was grade iv chondromalacia on the medial patellar facet with articular cartilage ridging in the femoral trochlea.The injury was reconstructed using a single longitudinal lag screw and tension band wire (3.5-mm cortical screw [synthes, (b)(4)]; 18-gauge stainless-steel cerclage wire), along with retinacular repair.The knee was placed in an immobilizer, and the patient was instructed in partial weight-bearing.At 5 weeks, the immobilizer was discontinued, and the patient began full weight-bearing at 2 months.Despite the return of nearly full range of motion, follow-up at 13 months after surgery revealed complaints of swelling and mild pain after prolonged standing.Radiographs at this time clearly demonstrated a nonunion, with a loosening of the device.Device removal in combination with excision of the patellar distal pole was discussed and declined by the patient.At last follow-up 8 years postoperatively, the patient has only minimal pain and a subjective sensation of swelling after prolonged activity or standing.The range of motion reveals 0 out of 130 on the right versus 0 out of 135 on the left, with no extensor lag.The circumference of the knee is 39.0 cm right and 37.5 cm left.Lachman, mcmurray, and anterior drawer tests are negative.Radiographs (obtained 6 years postoperatively) reveal a stable nonunion of the distal pole of the patella with a fracture of the cerclage wire.The patient continues to decline device removal 8 years postoperatively.This report is for an unknown synthes single longitudinal lag screw and tension band wire.This is 2 of 3 for report (b)(4).

• Brand Name: UNK - SCREWS: LAG
• Type of Device: SCREW,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 9244492
• MDR Text Key: 173913707
• Report Number: 2939274-2019-61781
• Device Sequence Number: 1
• Product Code: HWC
• 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: Physician
• Type of Report: Initial
• Report Date: 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR