MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.7MM/3.5MM TI LCP LAT DISTAL FIBULA PLATE 6H/RIGHT/112MM; PLATE, FIXATION, BONE

Catalog Number 04.112.142

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

Patient Problem Injury (2348)

Event Date 09/01/2020

Event Type  Injury  

Manufacturer Narrative

Additional procode: hwc.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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

Device report from (b)(6) reports an event as follows: it was reported that a distal tibia fx surgery was performed on (b)(6) 2020.During the procedure, the doctor requested the lateral distal fibular plates, but there were no 3.5 screws because they were still in sterilization.The surgeon asked the sales representative if the placement of 2.7mm cortical screws in the body of the fibular plate but in the locking hole would work.The representative told the doctor that the indication would be 3.5 mm and that the 2.7mm could generate complications in the patient, however, the doctor proceeded to perform the surgery, knowing that the screws indicated for the body of the plate were 3.5mm.Procedure was completed successfully with no delay.Patient was stable following surgery; there were no patient consequences.This report is for a 2.7mm/3.5mm titanium (ti) locking compression plate (lcp) lateral distal fibula plate.This is report 10 of 10 for (b)(4).

• Brand Name: 2.7MM/3.5MM TI LCP LAT DISTAL FIBULA PLATE 6H/RIGHT/112MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: karaa ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10593047
• MDR Text Key: 208773080
• Report Number: 8030965-2020-07482
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819382824
• UDI-Public: (01)07611819382824
• Combination Product (y/n): N
• Reporter Country Code: CS
• PMA/PMN Number: K083213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.112.142
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2020
• 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
• Treatment: 2.7MM TI LOCKING SCREW; CORTSCR Ø2.7 SELF-TAP L16 TAN; CORTSCR Ø2.7 SELF-TAP L16 TAN; CORTSCR Ø2.7 SELF-TAP L18 TAN; CORTSCR Ø2.7 SELF-TAP L34 TAN; CORTSCR Ø2.7 SELF-TAP L34 TAN; LOCKSCR Ø2.7 HEAD LCP2.4 SELF-TAP L12 TA; LOCKSCR Ø2.7 HEAD LCP2.4 SELF-TAP L12 TA; LOCKSCR Ø2.7 HEAD LCP2.4 SELF-TAP L12 TA
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR