MAUDE Adverse Event Report: SYNTHES GMBH TFNA END CAP EXTENS. 0 TAN; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 04.038.000S

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

Patient Problem Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

Product complaint :(b)(4).Additional narrative: 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: update on 16.04.2021 the lot number 3l10411 does not exist in sap p02.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 europe reports an event in japan as follows: it was reported that on (b)(6) 2021, it was confirmed that the patient who underwent tfna surgery at this hospital on (b)(6) 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 end cap extens.0 tan this report is 1 of 4 for (b)(6).

• Brand Name: TFNA END CAP EXTENS. 0 TAN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kara ditty-bovard ; 1392 wrights lane east; west chester, PA
• MDR Report Key: 11717663
• MDR Text Key: 247089335
• Report Number: 8030965-2021-03212
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819648708
• UDI-Public: (01)07611819648708
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K160167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.038.000S
• Device Lot Number: 3L10411
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: LOCKSCR Ø5 L36 F/NAILS TAN; TFNA END CAP EXTENS. 0 TAN; TFNA FEM NAIL 12 125 L200 TI; TFNA HELICAL BLADE L100 TAN
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR