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

Device Problem Device Slipped (1584)

Patient Problems Pain (1994); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown screws/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: degeorge jr.B, brogan d, becker h, shin a (2020), incidence of complications following volar locking plate fixation of distal radius fractures: an analysis of 647 cases, plastic and reconstructive surgery, volume 4, page 969-976, (usa).The primary focus of this study was to report the type and rate of complications of open reduction and internal fixation of distal radius fractures fixed with a volar locking plate at a single institution.Between may of 2000 and may of 2015, 647 distal radius fractures managed with volar plate fixation in 636 patients.Were included in the study.There were 493 females and 154 with a mean age of 56.5 years, with a range of 18 to 93 years.32.8 percent of these patients met the world health organization criteria for obesity.The majority of distal radius fractures were managed with a competitor¿s fixed angle locked volar plate (69.6 percent of fractures), followed by the unknown synthes 2.4mm volar distal radius plate, then 2 other competitors¿ devices.Average follow-up was 9.1 months, with a range of 1.5 months to 8.9 years.The authors did not specify which patients were implanted with the synthes device.Thus, complications will be reported as follows: 40 patients had intraarticular, loose, or painful hardware requiring removal.8 patients had loose or painful hardware but elected not to proceed with recommended hardware removal.2 patients had extensor pollicis longus tendon rupture.1 patient had flexor pollicis longus tendon rupture.18 patients had reoperation with carpal tunnel release within 3 months of distal radius fixation.9 patients had reoperation for distal radioulnar joint instability.4 patients had reoperation for posttraumatic arthritis.3 patients had reoperation for tenolysis, repair, or tendon transfer.3 patients had reoperation for ulnar shortening, resection, or replacement.8 patients had malunion or loss of fixation.6 patients had delayed diagnosis of scapholunate injury.5 patients had major medical complications.3 patients had radial artery injury requiring repair.2 patients had permanent nerve injury.63 patients had transient paresthesias.16 patients had tendon irritation (5 flexor tendon and 11 extensor tendon).12 patients had stiffness or complex regional pain syndrome.11 patients had ulnar-sided wrist pain.11 patients had dequervain tenosynovitis.6 patients had delayed union.5 patients had surgical site infection or wound-related problem.This report is for an unknown synthes screws.It captures adverse events of intraarticular, loose, or painful hardware revised and loose or painful hardware elected with no removal.This is report 2 of 4 for (b)(4).

• Brand Name: UNK - SCREWS: TRAUMA
• 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: 10465323
• MDR Text Key: 207917422
• Report Number: 2939274-2020-03855
• 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: 08/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2020
• 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: 08/04/2020
• 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