MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.7MM TI CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 18MM; PLATE,FIXATION,BONE

Model Number 402.878

Device Problem Off-Label Use (1494)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 09/01/2020

Event Type  Injury  

Manufacturer Narrative

Additional procode: hwc.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 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 cortex screw slf-tpng with t8 stardrive recess 18mm.This is report 4 of 10 for (b)(4).

• Brand Name: 2.7MM TI CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 18MM
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK GRENCHEN (CH); solothurnstrasse 186; grenchen 2540 ; SZ 2540
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10587882
• MDR Text Key: 208742500
• Report Number: 8030965-2020-07456
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982206732
• UDI-Public: (01)10886982206732
• Combination Product (y/n): N
• Reporter Country Code: CS
• PMA/PMN Number: K112583
• 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: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 402.878
• Device Catalogue Number: 402.878
• 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
• Patient Age: 37 YR