MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: LCP DISTAL FIBULA PLATE/SCREWS; PLATE, BONE

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

Patient Problem Local Reaction (2035)

Event Type  Injury  

Event Description

Device report from synthes reports an event in japan as follows: this report is being filed after the review of the following journal article: harada s, et al.(2021), radiological assessments and clinical results of intra-articular osteotomy for traumatic osteoarthritis of the ankle, injury, volume 52, page 3516¿3527, https://doi.Org/10.1016/j.Injury.2021.08.022 (japan).The objectives of the study are to evaluate the effect of distal tibial oblique osteotomy, distal tibial intra-articular osteotomy, and distal fibular oblique osteotomy on the configuration of the ankle joint based on radiological assessment of the pre- and post-operative anterior-posterior and lateral weight-bearing radiographs of the ankle and to also report the clinical results obtained from patients who underwent intra-articular osteotomy.Between may 2010 to april 2018, 20 patients who underwent reconstruction for the treatment of traumatic ankle osteoarthritis were included in the study.There were 12 males and 8 females with a median age of 49 years old (range 14 to 87 years old).An unknown manufacturer¿s circular external fixator device was applied to 15 cases, unknown synthes locking compression plate to 3 cases, unknown synthes locking compression plate and unknown manufacturer¿s kirschner-wire to 1 case, and an unknown manufacturer¿s screw and k-wire to 1 case.Postoperatively, the patients are allowed to place the foot of their affected limb on the floor just after the surgery.Partial weight bearing is allowed at 6-8 weeks after the surgery.In general, only the active range of motion exercise is allowed.The average follow-up period was 42 ±23 months (range 19 to 121 months).Complications were reported as follows: case 4, a 30-year-old male had requested hardware removal due to symptoms caused by local irritation.Case 14, a 63-year-old female had requested hardware removal due to symptoms caused by local irritation.Case 15, a 87-year-old male had requested hardware removal due to symptoms caused by local irritation.Case 18, a 40-year-old male had requested hardware removal due to symptoms caused by local irritation.This report is for the unknown synthes distal tibia locking compression plates and screws, unknown synthes distal fibula locking plates and screws and unknown synthes medial distal tibia locking compression plates and screws.This is report 3 of 4 for complaint (b)(4).

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.This report is for an unk - constructs: lcp distal fibula plate/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)(6).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.

• Brand Name: UNK - CONSTRUCTS: LCP DISTAL FIBULA PLATE/SCREWS
• Type of Device: PLATE, 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: 15494502
• MDR Text Key: 300706057
• Report Number: 8030965-2022-07434
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2022
• 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: 11/30/2022
• 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
• Patient Age: 87 YR
• Patient Sex: Male