MAUDE Adverse Event Report: SYNTHES GMBH 10MM/125 DEG TI CANN TFNA170MM - STERILE; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.037.012S

Device Problem Migration (4003)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j representative.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing 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

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, the patient underwent the surgery for the trochanteric femur fracture with tfna system in question.The surgery was completed successfully without any surgical delay.On an unknown date, the patient felt pain when walking recently and visited the hospital.It was confirmed that the upper half had melted, and the pain was caused by the blade touching the acetabulum.The patient will undergo re-surgery for tha on (b)(6) 2021.It was unknown if the re-surgery completed successfully.No further information is available.This complaint involves four (4) devices.This report is for (1) 10mm/125 deg ti cann tfna170mm - sterile.This report is 2 of 4 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.H3, h4, h6: part # 04.037.012s; lot # 43p2198; manufacturing site: selzach; release to warehouse date: 14 feb2020; expiration date: 01 feb 2030; supplier: (b)(4).A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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.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: 10MM/125 DEG TI CANN TFNA170MM - STERILE
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12522612
• MDR Text Key: 273766178
• Report Number: 8030965-2021-07966
• Device Sequence Number: 1
• Product Code: HSB
• 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
• Report Date: 08/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.037.012S
• Device Lot Number: 43P2198
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/30/2021
• Patient Sequence Number: 1
• Treatment: LOCKSCR 5 L32 F/NAILS TAN LIGHT GREEN.; TFNA END CAP EXTENS. 0 TAN.; TFNA HELICAL BLADE L85 TAN.
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR