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

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

Patient Problem Joint Contracture (4528)

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.This report is for an unknown constructs: lcp hook plate/ screws /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).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

Device report from synthes reports an event in china as follows: this report is being filed after the review of the following journal article: gu h, et al (2022), combination of cable cerclage and hook plate for the fixation of comminuted fractures of inferior patellar pole: a review of 16 consecutive patients followed up for a minimum of 1 year, orthopaedic surgery volume 14, number 11, doi: 10.1111/os.13481 (china).The objective of the study is to present a new method consisting of cable cerclage and hook plate for fixating the comminuted inferior patellar pole fracture and evaluate the outcomes.Between january 2018 and september 2020, 16 patients who were treated with the construct of a cable cerclage in combination with a hook plate were included in the study.There were 8 males and 8 females with a mean age of 55.6+/-12.0 years (range, 41 to 73 years).During the procedure, a non-absorbable suture (#5 ethibond, ethicon) cerclage was used as a provisional suture.The patients were then implanted with an unknown synthes titanium cable and unknown synthes 3.5 mm hook plate.The wound was closed in layers with absorbable sutures (#2 vicryl, ethicon).No limitation or immobilization was necessary after the operation.Active and passive range of motion exercises (range, 20-30) and full weight bearing were encouraged as tolerated under the help of a physiotherapist during the first postoperative week.The mean follow-up period was 20.1 +/- 5.3 months (range 12¿31).Complications were reported as follows: case 16, a 53-year-old female had weakness and stiffness of the affected knee.Radiographs showed bone healing; the patient was prescribed a personalized rehabilitation program.Good results were seen at week 26.Case 8, a 66-year-old female had a flexion contracture.Case 13, a 73-year-old female had acute cellulitis that appeared 3 days postoperatively.Debridement with copious 0.9% saline irrigation was performed on day 4, without removing the implants.During the following inpatient period, the inflammation subsided.Patient also had a flexion contracture.A copy of the clinical evaluation form is being submitted with this regulatory report.This report involves one unk - constructs: lcp hook plate/ screws.This is report 4 of 6 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: LCP HOOK PLATE/ SCREWS
• Type of Device: PLATE, 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: 16086139
• MDR Text Key: 306527060
• Report Number: 8030965-2023-00004
• Device Sequence Number: 1
• Product Code: HRS
• 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: 01/03/2023
• 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: 12/07/2022
• 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
• Treatment: UNK - CABLE/WIRE: CERCLAGE CABLE.
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female