MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.7MM TI LOCKING SCR SLF-TPNG WITH T8 STARDRIVE RECESS-10MM; PLATE,FIXATION,BONE

Model Number	402.210
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional procode: hwc, ktt.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.
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020 during an open reduction fibula and tibia procedure, the surgeon implanted lateral distal fibular plates and used 2.7mm cortical screws in the body of the plate instead of the indicated 3.5mm screws.After a previous procedure, the surgeon directed the staff to retain 3.5mm screws and they were sent to be sterilized.The surgeon began the patient's procedure without the 3.5mm being available as they were still being sterilized.After being advised that using the 2.7mm cortical screws could generated complications in the patient, the surgeon proceeded to implant the 2.7mm cortical screws.There is no further information available.This report is for one (1) 2.7mm ti locking scr slf-tpng with t8 stardrive recess-10mm.This is report 1 of 10 for (b)(4).

• Brand Name: 2.7MM TI LOCKING SCR SLF-TPNG WITH T8 STARDRIVE RECESS-10MM
• Common Device Name: PLATE,FIXATION,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10587682
• Report Number: 8030965-2020-07449
• Device Sequence Number: 2822335
• Product Code: HRS
• UDI-Device Identifier: 10886982205728
• UDI-Public: (01)10886982205728
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• PMA/510(K) Number: K113364
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 09/01/2020

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
• Operator of Device: Health Professional
• Device Model Number: 402.210
• Device Catalogue Number: 402.210
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/01/2020
• Initial Report FDA Received Date: 09/25/2020
• Patient Sequence Number: 1
• Patient Age: 37 YR