MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.7MM/3.5MM LCP LATERAL DISTAL FIBULA PLATE 4H/RIGHT/86MM; PLATE,FIXATION,BONE

Model Number 02.112.138

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/21/2020

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Occupation: reporter is a synthes employee.The investigation could not be completed; no conclusion could be drawn, as no product was received.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

It was reported that on (b)(6) 2020 during an osteosynthesis of the left distal perone that an adverse event occured.When the surgeon requested the plaque, the opposite laterality plaque was passed and placed in the patient.Concomitant medical product: unknown screws (part # unknown, lot # unknown, quantity unknown).This report is for one 2.7mm/3.5mm lcp lateral distal fibula plate 4h/right/86mm.This is report 1 of 1 for (b)(4).

• Brand Name: 2.7MM/3.5MM LCP LATERAL DISTAL FIBULA PLATE 4H/RIGHT/86MM
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 9860444
• MDR Text Key: 190497534
• Report Number: 8030965-2020-02142
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982033895
• UDI-Public: (01)10886982033895
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 02.112.138
• Device Catalogue Number: 02.112.138
• Device Lot Number: 20P0959
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2020
• Initial Date FDA Received: 03/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2019
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1