MAUDE Adverse Event Report: SYNTHES GMBH TFNA FEM NAIL 12 130 L200 TIMO15; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.037.243S

Device Problems Break (1069); Device-Device Incompatibility (2919)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/24/2021

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j employee.Without a lot number the device history records review could not be completed.Product was not returned.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 on (b)(6) 2021, the patient underwent revision surgery to have a broken tfna nail explanted.The tfna implant was originally placed in the patient on (b)(6) 2021.The nail broke at the section where the blade passes through the nail.The surgeon experienced difficulty when extracting the broken tfna nail.The surgeon ultimately used bent cerclage wires to grasp the end of the nail and remove it.There was a surgical delay of one-hundred-six (106) minutes.The procedure was successfully completed.Concomitant devices reported: unknown tfna blade (part# unknown, lot# unknown, quantity 1).This report is for one (1) 11mm/130 deg ti cann tfna 200mm - sterile.This is report 1 of 1 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: 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.H3, h4, h6- the complaint condition could be confirmed for the returned device as the returned device was observed to be cracked.The cracked device could have caused the complaint condition.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied to the device.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot =manufacturing location: monument.Manufacturing date: 11-may-2020, expiration date: 01-apr-2030.Part number: 04.037.243s, 12mm/130 deg ti cann tfna 200mm - sterile, lot number: 54p6072 (sterile), component part(s) reviewed: part number: 04.037.912.3, tfna lock drive, lot number: 47p8898.Part number: 04.037.912.4, wave spring, shim ended, lot number: 45p7086.Part number: 04.037.942.2, lock prong, 130 degree, tfna, lot number: 31p7541.Part number: 21127, timoagri16.00, lot number: 35p5569.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.

• Brand Name: TFNA FEM NAIL 12 130 L200 TIMO15
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf PA 4436 ; SZ 4436
• MDR Report Key: 11734730
• MDR Text Key: 247907532
• Report Number: 2939274-2021-02109
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819650510
• UDI-Public: (01)07611819650510
• Combination Product (y/n): N
• PMA/PMN Number: K160167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.037.243S
• Device Lot Number: 54P6072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2021
• Date Manufacturer Received: 07/20/2021
• Patient Sequence Number: 1
• Treatment: UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE; UNK - SCREWS: LOCKING
• Patient Outcome(s): Required Intervention