MAUDE Adverse Event Report: SYNTHES GMBH UNK - SCREWS: VA LOCKING; SCREW, FIXATION, BONE

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

Patient Problems Arthritis (1723); Pain (1994); Joint Dislocation (2374)

Event Type  Injury  

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: this report is for an unknown screws: va locking/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: sun, c, et al.(2022), lisfranc injuries with dislocation the first tarsometatarsal joint: primary arthrodesis or internal fixation (a randomized controlled trial), international orthopaedics https://doi.(b)(4).The purpose of this study was to compare open reduction and internal fixation (orif) and primary arthrodesis of the first tarsometatarsal joint for lisfranc injuries with the first tarsometatarsal joint dislocation.From january 2016 to january 2021, 78 patients with lisfranc injuries with first tarsometatarsal joint dislocation were randomized to treatment with either open reduction and internal fixation or primary arthrodesis were included in the study.There were 50 males and females with a mean age of 40.7 years.A total of 48 patients were treated with orif and were implanted with an unknown synthes tarsometatarsal bridging plates as well as an unknown manufacturer 2.7 mm cortical screws and an unknown manufacturer k-wires.There were 30 patients who were treated with primary arthrodesis with the exact same approach and principles used as that in performing open reduction and internal fixation.The only additional step was that the articular cartilage was removed from both the surfaces of the first tarsometatarsal joint.Post-operatively, the patients wore a short leg splint for 2 weeks and had a short leg cast for 4 to 6 weeks.Partial weight bearing began at 6 weeks when cast immobilization and the k-wires were removed.Patients were followed at 3 weeks, 6 weeks, 3 months, 6 months, and 12 months postoperatively.For orif group, the bridging plate over the first tarsometatarsal joint was removed as planned between 3 and 4 months post-operatively.Complications were reported as follows: 6 patients had loosened or broken plates.10 patients had redislocation of the first tarsometatarsal joint.6 were asymptomatic and 4 were painful on the midfoot and required revision.15 patients had pain in their midfoot.8 of them had persistent pain with the development of deformity or osteoarthritis, and 4 patients among them were eventually revised with arthrodesis, while the others received conservative treatment such as taking pain killers.2 patients had painful hardware and the symptom disappeared after removal of the hardware.A copy of the literature article is being submitted with this regulatory report.This report involves one unk - screws: va locking.This is report 2 of 2 for (b)(4).

• Brand Name: UNK - SCREWS: VA LOCKING
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15395607
• MDR Text Key: 299663468
• Report Number: 8030965-2022-06590
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2022
• 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: 08/17/2022
• 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