MAUDE Adverse Event Report: SYNTHES GMBH 5.0MM TI LOCKING SCR SLF-TPNG W/T25 STARDRIVE 44MM-STERILE; APPLIANCE,FIXATION,NAIL

Catalog Number 412.216S

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

Patient Problems Skin Inflammation/ Irritation (4545); Unspecified Tissue Injury (4559)

Event Date 10/28/2020

Event Type  Injury  

Manufacturer Narrative

The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.Device history lot: part: 412.216s, lot: 1l68285, manufacturing site: (b)(4), supplier: (b)(4), release to warehouse date: oct 01, 2018, expiry date: sep 01, 2028.Since there is no allegation against packing or sterility dhr review is done for non-sterile part: part number: 412.216, lot number: 1l43781, manufacturing site: (b)(4), release to warehouse date: sep 17, 2018.A manufacturing record evaluation was performed for the non-sterile device lot number, and no non-conformance were identified.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 (b)(6) reports an event as follows: it was reported that on an unknown date, the patients suffered from a medial colum fracture of the femur.All healed well.But he developed irritations caused by the implant under the soft tissue.So, implant removal was planned.No comorbidities.The surgery was completed successfully without delay.There was no patient consequence.This complaint involves four (4) devices.This report is for (1) 5.0mm ti locking scr slf-tpng w/t25 stardrive 44mm-sterile.This report is 1 of 4 for (b)(4).Related product complaint: (b)(4).

• Brand Name: 5.0MM TI LOCKING SCR SLF-TPNG W/T25 STARDRIVE 44MM-STERILE
• Type of Device: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10924476
• MDR Text Key: 218968135
• Report Number: 8030965-2020-09274
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 07611819152373
• UDI-Public: (01)07611819152373
• Combination Product (y/n): N
• PMA/PMN Number: K000682
• 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: 11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 412.216S
• Device Lot Number: 1L68285
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/02/2020
• Patient Sequence Number: 1
• Treatment: UNK - NAIL HEAD ELEMENTS: FNS ANTIROTATION; UNK - NAIL HEAD ELEMENTS: FNS BOLT; UNK - PLATES: FNS; UNK - NAIL HEAD ELEMENTS: FNS ANTIROTATION; UNK - NAIL HEAD ELEMENTS: FNS BOLT; UNK - PLATES: FNS
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Weight: 79