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

Device Problems Break (1069); Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

This report is for an unknown locking 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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: fuentes, a.M., et al.(2014), percutaneous osteosynthesis in tibial pilon fractures.Does the surgical technique determine the final result?, revista española de cirugía ortopédica y traumatología, vol.58(5), pages 290-296 (spain).The objective of our study was to carry out a comparative analysis of the clinical and functional results of two types of percutaneous techniques, employed for the management of metaphyseal fractures of the distal tibia, with or without intraarticular involvement.Between 2001 and 2012, a total of 33 patients were included in the study which was divided into 2 groups.The 1st group (g1) was composed of 16 patients (8 males and 8 females) with a mean age of 49.9 years (range: 25-79 years) were treated with plates locked in a medial position (lcp synthes).The 2nd group (g2) consisted of 17 patients (11 males and 6 females) with a mean age of 49.6 years (range: 28-84 years) were treated with a cannulated ao 7.3mm screws in a cross or x shape.All patients were monitored at least until clinical andradiological consolidation took place, with a mean follow-up period of 17.4 months (range: 12---60 months) in g1 and28.5 months (range: 12---60 months) in g2.The following complications were reported as follows: g1 group.2 patients had poor results.1 patient had an instance of consolidation delay which achieved fracture union 10 months after the first intervention and without requiring a second intervention.A (b)(6) year-old female patient with diabetes miletus had superficial infection.A second intervention was necessary to remove the material or debride the affected area.A (b)(6) year-old female patient had superficial infection.A second intervention was necessary to remove the material or debride the affected area.A (b)(6) year-old male patient had with a wrist fracture had superficial infection.A second intervention was necessary to remove the material or debride the affected area.A (b)(6) year-old male patient with chest trauma and a mild traumatic brain injury had superficial infection.A second intervention was necessary to remove the material or debride the affected area.2 patients suffered loosening or breakage of screws but neither required a second intervention to achieve consolidation of the fracture.G2 group.15 patients required a new manipulation to extract the cannulated screws approximately 1 year after the surgery and once the fracture had become consolidated.The size of the screws and their percutaneous juxtamalleolar disposition could lead to discomfort related to the material.This is report 6 of 7 for (b)(4).This report is for unknown locking screws.

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.H3, h4, h6: 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 - SCREWS: LOCKING
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9162248
• MDR Text Key: 200011543
• Report Number: 8030965-2019-69102
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/10/2019
• Patient Sequence Number: 1