MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: 3.5 MM LCP EXTRA-ARTICULAR DISTAL HUMERUS PLATE; PLATE, FIXATION, BONE

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

Patient Problems Discomfort (2330); Skin Inflammation/ Irritation (4545)

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.Brand name, common device name, procode, manufacturer name, city and state, product information, pma/510k: this report is for an unknown plates: 3.5 mm lcp extra-articular distal humerus plate/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

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: jung, h.S., won, y.S., choi, y.S.And lee, j.S.(2022), risk factors for hardware related complications after extra articular distal humerus fracture fixation using an anatomical locking plate, european journal of trauma and emergency surgery, vol.Xx (xx), pages 1-7 (south korea).The aim of this retrospective study is to identify the incidence and risk factors of hardware-related complications in patients treated with anatomical locking plate fixation for extraarticular distal humerus fractures.Between january 2013 to december 2020, a total 33 patients were treated fracture fixation was accomplished by applying a 3.5 mm extra-articular distal humerus locking plate (eadhp) (depuy synthes, inc.) on the posterior surface of the humerus.4 patients were excluded because of incomplete clinical or radiographic records (n=3) or an additional plate used with the eadhp (n=1).The remaining 29 patients included group a, n=10 (3 female and 7 male), and group b, n=19 (7 female and 12 male) with a mean age of 34.5 ± 17.6 (range 21¿75 years).On axial ct, hardware protrusion on the lateral aspect of the distal humerus was evaluated.The presence/absence of hardware-related complications was investigated.Hardware-related complications were defined as the occurrence of skin prominence on the plate and subsequent discomfort in activities of daily living at the final follow-up (fig.1).The decision to perform hardware removal surgery was made by the patient and surgeon together based on the patient¿s needs and discomfort due to hardware insertion.The number of patients who underwent hardware removal was significantly greater in group b (16/19) than in group a (4/10).However, the lateral body length was greater in group a than in group b (44.5 ± 4.8 vs.39.5 ± 3.7, p = 0.007).The plate length also significantly differed between the two groups (p = 0.008).12 of 19 (63%) patients in group b used short-hole plates (six holes), while 9 of 10 (90%) patients in group a used long-hole plates (eight holes).The following complications were reported as follows: n=19 patients of group b that used short-hole plates (six holes) developed 66% hardware-related complications.A 26-year-old man reports skin prominence and discomfort during activities of daily living and requests implant removal at final follow-up.1 out of 10 of group a and all of 19 patients of group b had hardware protrusion.4 out of 10 of group a and 16 out of 19 patients of group b underwent hardware removal.This report involves one unk - plates: 3.5 mm lcp extra-articular distal humerus plate.This is report 2 of 2 for (b)(4).

• Brand Name: UNK - PLATES: 3.5 MM LCP EXTRA-ARTICULAR DISTAL HUMERUS 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 19380 ; 3035526892
• MDR Report Key: 16430008
• MDR Text Key: 310129446
• Report Number: 8030965-2023-02239
• 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,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: 02/23/2023
• 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: 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
• Patient Outcome(s): Required Intervention
• Patient Age: 26 YR
• Patient Sex: Male