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

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

Patient Problems Loss of Range of Motion (2032); Injury (2348); Non-union Bone Fracture (2369); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown dual 3.5 mm lcp construct/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)(4).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

This report is being filed after the review of the following journal article: seo, j.-b., heo, k., yang, j.-h., and yoo, j.-s.(2019), clinical outcomes of dual 3.5-mm locking compression plate fixation for humeral shaft fractures: comparison with single 4.5-mm locking compression plate fixation, journal of orthopaedic surgery, vol.27 (2), pages 1-6, https://doi.Org/10.1177/2309499019839608 ((b)(6)).The aim of this is to report the outcomes of dual small (3.5-mm) plating for humeral shaft fractures in comparison with those of single large (4.5-mm) fragment plating.Between september 2014 to december 2017, a total of 60 patients (20 male and 40 female), with ages ranging from 18 to 83 years, underwent an open reduction internal fixation (orif).Single 4.5-mm locking compression plate (lcp) fixation (synthes, solothurn, switzerland) was used in the first 40 patients (29 male and 11 female) with a mean age of 43.6 ± 18.8 years, and dual 3.5-mm lcp fixation (synthes, solothurn, switzerland) was used in the final 20 patients (11 male and 9 female) with a mean age of 45.0±20.5 years.The mean follow-up was 13.7±3.8 months for single 4.5-mm lcp group and 9.3±3.1 months for dual 3.5-mm lcp group.The following complications were reported as follows: single 4.5 mm lcp group: union was observed 12 weeks after surgery in 31 (77.5%) of the 40 patients in the single plating group.In 7 patients (17.5%), healing took longer during the follow-up period.1 patient showed metal failure at 24 weeks.3 patients had slightly reduced elbow rom at 12 weeks after surgery.3 patients developed radial nerve palsy after surgery, probably owing to operative manipulation.They returned to normal function from 6 to 12 weeks after surgery.1 patient showed metal breakage with nonunion at 52 weeks after surgery.Dual 3.5 mm lcp group: union was observed 12 weeks after surgery in 15 (75%) of the 20 patients in the dual plating group.5 patients (25%) had longer healing times during follow-up.1 patient had a slightly reduced elbow extension at 12 weeks after surgery, although full elbow rom was restored at 24 weeks after surgery.1 patient developed radial nerve palsy after surgery, probably owing to operative manipulation.The patient recovered after receiving neurotrophic drugs at 24 weeks after surgery.This report is for an unknown synthes plate/screws constructs (dual 3.5 mm lcp).It captures the reported events of longer healing times during follow-up, slightly reduced elbow extension and radial nerve pals.A copy of the literature article is being submitted with this medwatch.This is report 3 of 4 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: PLATE/SCREWS
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10543843
• MDR Text Key: 215536862
• Report Number: 8030965-2020-07123
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2020
• 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: 08/21/2020
• 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