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
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/21/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: PLATE,FIXATION,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9860444
• Report Number: 8030965-2020-02142
• Device Sequence Number: 2373304
• Product Code: HRS
• UDI-Device Identifier: 10886982033895
• UDI-Public: (01)10886982033895
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K083213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 02.112.138
• Device Catalogue Number: 02.112.138
• Device Lot Number: 20P0959
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/21/2020
• Initial Report FDA Received Date: 03/20/2020
• Patient Sequence Number: 1