MAUDE Adverse Event Report: SYNTHES GMBH TFNA HELICAL BLADE 100MM STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	04.038.300S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary: 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 complainant device is not expected to be returned for manufacturer review/investigation device history lot.Manufacturing location: elmira / monument.Manufacturing date: 09-jan-2016.Expiration date: 01-dec-2025.Part number: 04.038.300s, 10.5mm tfna helical blade 100mm -sterile.Lot number: 9961107 (sterile).Lot quantity: 48.Work order traveler met all inspection acceptance criteria.Inspection sheet, inspect 1 / final inspection, met all inspection acceptance criteria.Packaging label log lppf, lmd/lpf rev ab was reviewed and determined to be conforming.Scn 12113 supplied by (b)(6) was reviewed and determined to be conforming.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Device history batch null, device history review 12-apr-2021: dhr this lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.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 (b)(6) reports an event in japan as follows: it was reported that on march 29, 2021, it was confirmed that the patient who underwent tfna surgery at this hospital on june 3, 2019 developed wound infection.The surgeon commented that the distal end of the telescoped blade protruded into the skin, which may have caused a wound on the skin and caused an infection.Since bone union has already been achieved in this case, not only the blade but also all the implants will be removed in the future.No further information is available.This complaint involves four (4) devices.This report is for one (1) tfna fem nail 12 125 l200 ti.This report is 4 of 4 for (b)(4).

• Brand Name: TFNA HELICAL BLADE 100MM STERILE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11719474
• Report Number: 8030965-2021-03223
• Device Sequence Number: 3921751
• Product Code: HSB
• UDI-Device Identifier: 10886982099037
• UDI-Public: (01)10886982099037
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K131548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/30/2021

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 Expiration Date: 12/01/2025
• Device Model Number: 04.038.300S
• Device Catalogue Number: 04.038.300S
• Device Lot Number: 9961107
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 04/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR