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

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

Patient Problems Bone Fracture(s) (1870); Nerve Damage (1979); Pain (1994); Loss of Range of Motion (2032)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Event date is unknown.This report is for an unk - constructs: 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.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed and no conclusion could be drawn at the time of filing this report.Product was not returned.Based on the information available, it has been determined that no corrective and 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 united kingdom as follows: this report is being filed after the review of the following journal article: clement, n.D.Et al (2012), retention of forearm plates: risks and benefits in a paediatric population, the journal of bone and joint surgery.British volume vol.94-b (1), pages 134-137, https://doi.Org/10.1302/0301-620x.94b1.27155 (united kingdom).The aim of this prospective case series study is to identify complication rates following retention of a plate and to compare these with the published complication rates following removal of a plate.Secondary aims are to identify risk factors associated with complications of plate retention.Between january 2000 to december 2007, a total of 82 patients (52 male and 30 female) with a mean age of 9.1 years (4 to 13) were included in the study.Both bones were fractured in 77 patients, with three having isolated radial and two having isolated ulnar fractures.Both bones were plated in 34 patients, the ulna alone was plated in 20 patients, and the radius alone was plated in 28 patients.There were 116 plates in total, 79 one-third tubular plates (unknown manufacturer) and 37 dynamic compression plates (dcp).The mean follow-up was 6.2 years (2 to 10).The following complications were reported: early postoperative complications included 2 (2.4%) superficial wound infections, 2 (2.4%) superficial radial nerve deficits and 1 patient (1.2%) with marked limitation of supination who underwent revision of fixation.6 patients had implant-related fracture.One of these occurred before one year; the other five occurred between 19 and 34 months after fixation (fig.2).The plate was revised following fracture in all except one patient, in whom the fracture was minimally displaced and managed conservatively.One patient sustained a superficial radial nerve injury during revision.5 patients had pain/irritation and underwent removal of the plate with resolution of their symptoms and no complications.1 patient had stiffness/limitation of supination and underwent removal of the plate with resolution of their symptoms and no complications.3 patients had screw extrusion/loose screws that had either partially or totally disassociated from the plate.The screws were removed without incident and revision of the plate was not necessary.A (b)(6) patient had an implant-related fracture.This report is for an unknown synthes dynamic compression plate/screws constructs and unknown synthes screws.This report is for (1) unk - constructs: plate/screws.This report is 1 of 3 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: PLATE/SCREWS
• Type of Device: SCREW,FIXATION,BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11483414
• MDR Text Key: 241061385
• Report Number: 8030965-2021-01934
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 02/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2021
• 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: 02/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention