MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 36MM F/IM NAIL-STER; SCREW,FIXATION,BONE

Catalog Number 04.005.526S

Device Problem Unintended Movement (3026)

Patient Problem Unspecified Infection (1930)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown date in 2019.Device evaluated by mfr: 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

Device report from synthes reports an event in (b)(6) as follows: it was reported that the patient underwent a debridement and hardware removal surgery on (b)(6) 2019.The patient was initially with the expert tibial nail system on (b)(6) 2019, due to a fibula diaphyseal fracture.On (b)(6) 2019, the patient visited the hospital and post-operative course was good.(b)(6) 2019, the patient visited the hospital again and reported swelling of the affected area and was suspected of infection.The hospital planned to remove one loosened screw in the debridement surgery.During the debridement surgery, the other screws lost their fixation and the infection spread through the implants from the lesion.The surgeon removed all etn implants and applied a vacuum-assisted closure therapy.The patient is under follow-up and will be applied external fixation after the affected area becomes stable.There is a possibility of lower limb amputation due to gangrenous five fingers.The surgeon reported that after (b)(6) 2019, the patient developed purulent meningitis from an unknown cause and there was no problem with the devices.There was a surgical delay of ninety (90) minutes.Procedure and patient outcome are unknown.This report is for one (1) 5.0mm ti locking screw w/t25 stardrive 36mm f/im nail-ster.This is report 3 of 7 for (b)(4).

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.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.Product was not returned.Based on the information available, it has been determined that no corrective and 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.Part: 04.005.526s.Lot: 2l06942.Manufacturing site: selzach.Supplier: früh verpackungstechnik ag.Release to warehouse date: 26.October 2018.Expiry date: 01.October 2028.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Non-sterile 04.05.526 / 1l98438 was manufactured in mezzovico.Part: 04.005.526.Lot: 1l98438.Manufacturing site: mezzovico.Release to warehouse date: 16.October 2018.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.

• Brand Name: 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 36MM F/IM NAIL-STER
• Type of Device: SCREW,FIXATION,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8569472
• MDR Text Key: 143705949
• Report Number: 8030965-2019-63333
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 07611819789814
• UDI-Public: (01)07611819789814
• Combination Product (y/n): N
• PMA/PMN Number: K172157
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/03/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 04.005.526S
• Device Lot Number: 2L06942
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/03/2019
• Initial Date FDA Received: 05/01/2019
• Supplement Dates Manufacturer Received: 05/21/2019
• Supplement Dates FDA Received: 06/17/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 70