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

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

Patient Problem Reaction (2414)

Event Date 01/14/2019

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown synthes philos screw /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

This report is being filed after the review of the following journal article: borer j., et al (2020)mid-term results of minimally invasive deltoid-split versus standard open deltopectoral approach for philos¿ (proximal humeral internal locking system) osteosynthesis in proximal humeral fractures, european journal of trauma and emergency surgery volume 46, pages 825¿834 ((b)(6)).This study aims to compare the clinical and radiological outcomes of the open deltopectoral (dp) approach with the minimally invasive deltoid-split (mids) approach for philos¿ osteosynthesis in patients with fractures of the proximal humerus after a minimal follow-up time of 1 year.Between january 2008 and july 2015,148 patients underwent philos¿ osteosynthesis in proximal humerus fractures.62 patients with mean age of 64 years (58¿73) were available for the clinical and radiological follow-up.The patients were divided into two groups according to the surgical approach, the mids group and the dp group, respectively.Of the 62 study participants, 39 underwent the mids and 23 the dp approach.For the dp approach the fracture was then reduced and a 3-hole philos¿ plate applied using 5¿7 mono-cortical locking head screws (lhs) for the mids approach a 5-hole plate was inserted using the specific percutaneous aiming system for philos¿.Follow-up time was significantly shorter in the mids group with a median of 41 months (iqr 24¿54) compared to 62 months (iqr 42¿88) in the dp group.The following complications were reported as follows: death in 32 patients (lost to follow-up).One patient in each group had a total avascular necrosis and ten patients in the mids group showed radiological signs for partial avascular necrosis compared to three patients in the dp group.Subacromial impingement, mids: 10 (26) dp:5 (22) in a total of 22 patients 23 reoperations were performed.Reoperation, 23 (37) mids:14 (36) dp: 9 (39).In the other 21 patients, all reoperations were plate removals.The reasons for plate removal were subacromial impingement in 11 , plate discomfort in five, decreased range of motion or frozen shoulder in two , and explicit wish in four patients.Plate removal, 22 (35) mids 13 (33) dp: 9 (39).One patient in the mids group required two operations, first the shortening of a screw and later the removal of the plate.The analysis of the early and mid-term radiological follow- up revealed a number of screw perforations.At 6 week postsurgery, a total of four patients showed a screw perforation and three of them in the mids group.At 6¿12 month follow-up, four further screw perforations were detected, one of them in the mids group.Secondary screw perforation: mids- 4 dp-4.This is report 8 of 8 for (b)(4).This complaint is linked to (b)(4).This report is for an unknown synthes philos screw.A copy of the literature article is being submitted with this report.

• Brand Name: UNK - SCREWS: TRAUMA
• 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: 10707692
• MDR Text Key: 216416505
• Report Number: 8030965-2020-08074
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• 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: 10/05/2020
• 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