MAUDE Adverse Event Report: SYNTHES GMBH 11MM TI CANNULATED TIBIAL NAIL-EX/360MM-STERILE; NAIL,FIXATION,BONE

Catalog Number 04.004.552S

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

Patient Problems Hematoma (1884); Impaired Healing (2378); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is j&j employee.(b)(4).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 suffered from poor wound healing postoperatively.On (b)(6) 2019, patient was implanted with tibial nail system.On (b)(6) 2020, a local hematoma was formed in the right lower leg, and the anteromedial side of the distal right calf formed a sinus with a diameter of about 5 mm.The internal fixation device was removed and proper treatments were given on (b)(6) 2020.No further information was provided.Concomitant devices reported: expert tn ø11 cann l360 tan light green (part # 04.004.552s, lot # l819192, quantity 1); end caps (part # unknown, lot # unknown, quantity unknown).This report is for one (1) 11mm ti cannulated tibial nail-ex/360mm-sterile.This is report 1 of 3 for complaint (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.

Event Description

Concomitant devices reported: locking screws (part # unknown, lot # unknown, quantity unknown); end caps (part # unknown, lot # unknown, quantity unknown).

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.H3, h6: investigation summary device history was reviewed.Device history lot part: 04.004.552s, lot: l819192, manufacturing site: selzach, supplier: (b)(4), release to warehouse date: march 16, 2018, expiry date: march 01, 2028.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Non - sterile part part: 04.004.552, lot: l796847, manufacturing site: mezzovico, release to warehouse date: march 02, 2018.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances 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.

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.

• Brand Name: 11MM TI CANNULATED TIBIAL NAIL-EX/360MM-STERILE
• Type of Device: NAIL,FIXATION,BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10029364
• MDR Text Key: 194511665
• Report Number: 8030965-2020-03330
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 07611819199293
• UDI-Public: (01)07611819199293
• Combination Product (y/n): N
• PMA/PMN Number: K040762
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.004.552S
• Device Lot Number: L819192
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/27/2021
• Patient Sequence Number: 1
• Treatment: UNK - END CAPS; UNK - SCREWS: LOCKING
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR