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

Device Problem Migration (4003)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

Device report from synthes reports an event in south korea as follows: this report is being filed after the review of the following journal article: park s-g, seok h-g (2022) bi columnar locking plate fixation through a combined medial and lateral approach for the treatment of low transcondylar fractures of the distal humerus in the elderly, bmc musculoskeletal disorders, volume 23, page 764, https://doi.Org/10.1186/s12891-022-05594-1 (south korea).The purpose of this study was to present the outcomes of bi-columnar internal fixation through a combined medial and lateral approach for the treatment of low transcondylar fractures of the distal humerus in the elderly.Between may 2017 and april 2020, 46 patients diagnosed with distal humeral fractures were included in the study.There were 3 males and 13 female patients, and the mean age of the patients was 81 years (range, 65¿91 years).During the procedure, a short locking compression plate the unknown synthes 2.7 mm variable angle lcp elbow system was used on the medial column and a long locking compression plate unknown synthes 3.5 mm variable angle lcp elbow system was used on the lateral column.Postoperatively, the elbow was placed in a bulky noncompressive dressing with a posterior plaster slab to keep the elbow flexed between 40 degrees and 50 degrees.Active-assisted and passive motion was encouraged 3 weeks after the surgical procedure.At 6 weeks, the patients were encouraged to regain rom of the elbow, and gentle daily activities were permitted.At 3 months, usual activity was allowed.Complications were reported as follows: patient 4, an 81-year-old male had screw migration with loss of reduction in varus during the early months after fixation.However, the fractures eventually healed without additional surgery.Patient 6, a 65-year-old female had stiffness or approximately 80 degrees of motion restriction (105 degrees of flexion, 35 degrees of extension) at 6 months after surgery.She regained a rom of about 110 degrees after removal of the instrument without the release of contracture.Patients 10, an 87-year-old female had medial skin necrosis over the ulnar plate that was identified 6 months after surgery.Since the fracture was healed, the hardware was removed, and the skin was debrided and re-sutured.A copy of the clinical evaluation form is being submitted with this regulatory report.This report involves one unk - screws: locking: variable angle.This is report 1 of 4 for (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.This report is for an unknown screws: locking: variable angle/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter facility address: (b)(6) hospital, 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 - SCREWS: LOCKING: VARIABLE ANGLE
• 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: 16436036
• MDR Text Key: 310151320
• Report Number: 8030965-2023-02274
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 02/24/2023
• 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: 02/02/2023
• 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
• Treatment: UNK - PLATES: VA-LCP DISTAL HUMERUS PLATES
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male