MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: 3.5 MM LCP HOOK PLATE; PLATE, FIXATION, BONE

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

Patient Problem Unspecified Tissue Injury (4559)

Event Date 11/20/2020

Event Type  Injury  

Event Description

This report is being filed after the review of the following journal article: lee w.Y., et al (2021) open reduction and stable internal fixation using a 3.5-mm locking hook plate for isolated fractures of the greater tuberosity of the humerus: a 2-year follow-up study using an innovative fixation method, clinics in orthopedic surgery ¿ vol.13, no.3, pages 1-8 (korea, south).This retrospective study aims to introduce a new surgical technique and to evaluate clinical and radiological outcomes of orif using a 3.5-mm locking hook plate for isolated gt fractures.Between january 2016 and january 2018, 27 patients with isolated gt fractures who underwent orif using a 3.5-mm locking hook plate were reviewed.Among these, 6 patients were excluded.Finally, 21 patients (7 men and 14 women) with a mean age of 64 years (range, 42¿82 years) were included.During surgery, a 3.5-mm locking hook plate (depuy synthes, west chester, pa, usa) was used to match the contour of the plate and the reduced fracture.After the contour was identified, the plate was bent and the distal sharp part of the hook of the plate was cut and rasped off to prevent damage to the rotator cuff by the hook.All patients underwent a second surgery for implant removal because even if the distal shaft part of the hook was cut and rasped off, the hook would still irritate the rotator cuff, and postoperative stiffness would be inevitable.The second surgery for implant removal was performed on all patients when union of the fracture was confirmed by radiography at 13¿22 weeks after the first surgery.After metal removal, the final follow-up was performed at an average of 27 months (range, 24¿36 months).The following complications were reported as follows: 1 patient had nonunion of the gt fracture due to trauma at 3 months.Vas pain score 4 (2¿8), before implant removal.2 developed rotator cuff tear due to a bursal side partial thickness tear of the rotator cuff as a result of irritation by the hook, and these patients underwent repair of the tear using a simple transosseous technique.This report is for an unknown synthes 3.5mm locking hook plate.This is report 1 of 1 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.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 unknown device/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.

• Brand Name: UNK - PLATES: 3.5 MM LCP HOOK PLATE
• 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 ; 3035526892
• MDR Report Key: 14845588
• MDR Text Key: 295070885
• Report Number: 8030965-2022-04431
• Device Sequence Number: 1
• Product Code: HRS
• 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
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2022
• 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: 06/01/2022
• 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): Other