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

Device Problems Break (1069); Device Slipped (1584); Migration (4003)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown screws: trauma/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.(b)(4).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

Device report from synthes reports an event in (b)(6) as follows: this report is being filed after the review of the following journal article: daniel, r.Et al (2015), the effect of local bone mineral density on the rate of mechanical failure after surgical treatment of distal radius fractures: a prospective multicentre cohort study including 249 patients, archives of orthopaedic and trauma surgery, vol.135 (xx), pages 201-207 (switzerland).The aim of this prospective, multicentre cohort study is to evaluate the outcome of bmd on the risk of mf in patients aged 50 years and older with a distal radius fracture treated operatively with a volar locking compression plate (lcp) 2.4 mm (synthes ag, switzerland).Between june 2007 to april 2010, a total of 249 patients (19 male and 230 female) with an average age of 67 years were included in the study.Surgery was performed using a volar locking compression plate (lcp) 2.4 mm (synthes ag, switzerland).The follow-up evaluations were at 6 weeks, 3 months and 1 year.The following complications were reported as follows: 9 patients (3 male and 6 female) were reported with mechanical failure (mf) within the 1-year follow-up period.Of these patients, 6 had experienced more than one mf complication.2 of these patients had a secondary screw perforation with loosening/back out.4 of these patients had implant (screw and plate) loosening.1 of these patients had implant failure/breakage.2 of these patients had screw failure/breakage.7 patients had a loss of reduction.3 patients had malunion due to loss of reduction.1 patient had fracture impaction.2 patients had delayed healing.1 patient experienced refracture/secondary fracture.This report is for an unknown synthes screws.This is report 8 of 10 for (b)(4).

• Brand Name: UNK - SCREWS: TRAUMA
• Type of Device: SCREW,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: 10358241
• MDR Text Key: 203297478
• Report Number: 8030965-2020-05573
• 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,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2020
• 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