MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 3.5MM TI LOCKING SCREW SELF-TAPPING 35MM; APPLIANCE,FIXATION,NAIL/BLADE/PLATE COMBO, SINGLE COMPONENT

Catalog Number 413.035S

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

Patient Problem Unspecified Infection (1930)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

Additional narrative: patient height reported as (b)(6).Patient identifier not available for reporting.Date of event reported as 2018, exact date patient infection began is not known.(b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.A review of the device history records has been requested.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 (b)(4) reports an event in (b)(6) as follows: it was reported patient underwent a procedure for a closed fracture of the tibia¿s diaphysis by a reduction and an osteosynthesis with tibial and fibular plates on (b)(6) 2018.Removal of the osteosynthesis material and placement of an external fixation were necessary due to scar flow.Patient was returned to surgery on (b)(6) 2018 for hardware removal.To remove the plates, surgeon cut the plates because two (2) screws had defective thread.Surgery was completed with a delay of approximately 2 hours.Patient status reported as stable.Patient is being treated with antibiotherapy for an osteoarticular infection.The defective screws are addressed in (b)(4).Patient infection is addressed in related complaints (b)(4).This report is for one (1) 3.5mm locking screw.This is report 7 of 12 for (b)(4).

Manufacturer Narrative

Synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Additional narrative: event: updated info.Device evaluated by mfr, device manufacture date: device history lot part: 413.035s lot: l755679, manufacturing site: selzach, supplier: il-medtec ag, release to warehouse date: 01.Feb.2018, expiry date: 01.Jan.2028.The sterilization history record shows that this lot of 238 pieces was processed through the normal sterilization and inspection operations with no non-conformity's noted.The irradiation certificate does certify that all readings are within the specified range.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.Device evaluated by mfr, device manufacture date: investigation summary: 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.

Event Description

Update: new information received from the customer on (b)(6) 2018 by phone: the infection occurred after the first surgery on (b)(6) 2018.The removal of the material on (b)(6) 2018 was caused by the infection and the scar flow.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Received by manufacturer date correction: remove 2/1/2018 from previous follow-up, and replace with 10/02/2018.Device was used for treatment, not diagnosis.

• Brand Name: 3.5MM TI LOCKING SCREW SELF-TAPPING 35MM
• Type of Device: APPLIANCE,FIXATION,NAIL/BLADE/PLATE COMBO, SINGLE COMPONENT
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7913850
• MDR Text Key: 121856623
• Report Number: 8030965-2018-56756
• Device Sequence Number: 1
• Product Code: KTW
• UDI-Device Identifier: 07611819268616
• UDI-Public: (01)07611819268616
• Combination Product (y/n): N
• PMA/PMN Number: K011815
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/29/2018

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 413.035S
• Device Lot Number: L755679
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/29/2018
• Initial Date FDA Received: 09/27/2018
• Supplement Dates Manufacturer Received: 02/01/2018; 11/07/2018
• Supplement Dates FDA Received: 10/18/2018; 11/07/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR
• Patient Weight: 70