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

Device Problem Device Slipped (1584)

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

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown screw/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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: foo tl, gan awt, soh t, chew wyc (2013), mechanical failure of the distal radius volar locking plate, journal of orthopaedic surgery, volume 21, page 332-336, (singapore).The purpose of this study is to review 9 cases of mechanical failure of the volar locking plate for distal radial fractures.Between june 2009 and june 2010, 9 patients with distal radius fractures who were treated with volar locking plating and had mechanical failures were included in the study.The patients were aged 25 to 82 (median, 74) years.The volar locking plates used included the unknown synthes 2.4-mm volar distal radius locking compression plate and 2 other competitors¿ devices.Postoperatively, the patients were fitted with removable wrist splints to facilitate protected mobilisation for 6 weeks.During follow-up (6 weeks to 2 years), pain score, range of motion, grip strength, radiographs, and green-o¿brien score were assessed.All patients were followed up for a minimum of 12 months.The authors did not specify which patients were implanted with the synthes device.Thus, complications will be reported as follows: an 82-year-old female patient had the plate bent at the metaphyseal region resulting in dorsal tilt of articular surface at 4 weeks postoperatively.She was asymptomatic and had adequate range of motion; revision surgery was not necessary.The patient achieved bone union at 3 months.(fig.1) a 60-year-old male patient had the plate bent at the metaphyseal region at 4 weeks postoperatively.He was asymptomatic and had adequate range of motion.The patients underwent implant removal for flexor tendon irritation.The patient achieved bone union at 3 months.An 80-year-old female patient had all 3 distal row screws broken at 12 weeks postoperatively resulting in loss of radial height and inclination and dorsal angulation of the articular fragment.The patient had minimal pain with satisfactory range of motion, and was therefore treated conservatively.(fig.2) an 82-year-old male patient had loosening of variable angle locking polyaxial screws resulted in dorsal tilt of the articular fragment and sudden onset of wrist pain during therapy at 2 weeks.Revision surgery was declined, and the wrist pain improved after 4 weeks of splinting.(fig.3) a 56-year-old female patient had shaft screw pullout at 3 weeks postoperatively and underwent revision surgery to correct the radial tilt with autologous bone grafting and dorsal plating.(fig.4) a 72-year-old male patient had a shaft screw pullout at 4 weeks postoperatively.The patient was treated conservatively and achieved bone union at 3 months postoperatively.A 76-year-old male patient had a shaft screw pullout at 6 weeks postoperatively.The patient was treated conservatively and achieved bone union at 6 months postoperatively.A 76-year-old male patient had a shaft screw pullout at 6 weeks postoperatively.The patient was treated conservatively and achieved bone union at 3 months postoperatively.This report is for unknown synthes screws.It captures 82-year-old male patient who had loosening of variable angle locking polyaxial screws and treated conservatively (fig.3).This is report 6 of 10 for (b)(4).Additional device is reported under related complaint (b)(4).

• Brand Name: UNK - SCREWS: LOCKING
• 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: 10465904
• MDR Text Key: 214433781
• Report Number: 8030965-2020-06427
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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: 08/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 08/04/2020
• Initial Date FDA Received: 08/28/2020
• 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
• Patient Age: 82 YR