MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - SCREWS: 3.0 MM CANNULATED; SCREW, FIXATION, BONE

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

Patient Problem Joint Disorder (2373)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown 3.0mm cannulated screw/unknown lot.Part and lot numbers are unknown; udi number is unknown.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.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.

Event Description

This report is being filed after the review of the following journal article: patillo d, khazzam m, robertson m, gainor bj (2010), outcome of percutaneous screw fixation of scaphoid fractures, journal of surgical orthopaedic advances, volume 19, page 114-120, (usa).This study presents a 3.2-year follow-up on patients who underwent percutaneous screw fixation of nondisplaced or minimally displaced scaphoid fractures over a 5-year period by a single surgeon.From january 2003 to october 2007, 18 patients who underwent percutaneous screw fixation of an acute or subacute scaphoid fracture were included in the study.There were 13 males and 5 females with a mean age of 30.4 years.The patients were implanted with an unknown ao 3.0mm cannulated screw.The patients had an average follow-up of 3.2 years included administration of dash questionnaire, physical examination, and final radiographs.Complications were reported as follows: patient 1, a (b)(6) year-old patient had a prominent screw on radiographic findings.Patient 2, a (b)(6) year-old female patient had a screw prominence and underwent screw removal.Patient 3, a (b)(6) year-old patient had a scapholunate or scaphotrapezial degenerative joint disease and scaphoid deformities on radiographic findings.Patient 4, a (b)(6) year-old patient had a prominent screw and delayed union requiring revision open reduction and internal fixation (orif).The fracture healed after the orif procedure.Patient 6, a (b)(6) year-old patient had a mild screw prominence on radiographic findings.Patient 7, a (b)(6) year-old patient had a screw prominence on radiographic findings.Patient 8, a (b)(6) year-old patient had a mild screw prominence on radiographic findings.Patient 10, a (b)(6) year-old patient had a mild screw prominence on radiographic findings.Patient 11, a (b)(6) year-old patient had a mild screw prominence on radiographic findings.Patient 13, a (b)(6) year-old patient had a carpometacarpal (cmc) joint arthritis and mild prominence on radiographic findings.Patient 16, a (b)(6) year-old patient had a mild joint irregularities and mild deformation on radiographic findings.Patient 17, a (b)(6) year-old patient had a nonunion or hardware failure and was revised with open reduction and internal fixation with iliac crest bone graft.This patient also had a prominent screw requiring removal).The fracture healed after the orif procedure.Patient 18, a (b)(6) year-old patient had 4.0mm scapholunate gap on follow-up x-ray.This is report 3 of 10 for (b)(4).This complaint is linked to (b)(4).This report is for the unknown ao 3.0mm cannulated screw.

• Brand Name: UNK - SCREWS: 3.0 MM CANNULATED
• 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: 9967537
• MDR Text Key: 194775237
• Report Number: 2939274-2020-01865
• 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: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2020
• 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: 21 YR