MAUDE Adverse Event Report: SYNTHES GMBH UNK - END CAPS: PFNA; ROD, FIXATION, INTRAMEDULLARY

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

Patient Problems Abscess (1690); Death (1802); Hematoma (1884); No Code Available (3191)

Event Date 01/01/2020

Event Type  Death  

Manufacturer Narrative

This report is for an unknown pfna end cap/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.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.(b)(4).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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2020 the patient was implanted with a hip prosthesis.On (b)(6) 2020 the patient underwent a removal operation of two (2) screws (1 cephalic screw and 1 distal screw) and the nail had been retrieved with repose of device due to a hematoma and abscess.The proximal femoral nail antirotation (pfna) blade was completely disunited.The surgeon retrieved four (4) separated parts from the patient.There was a surgical delay of less than 30 minutes.The patient died on (b)(6) 2020 of a probable septic shock.This report is for one (1) unknown pfna end cap.This is report 3 of 5 for (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).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.Event : updated information provided for reporting.Implant & explant day provided for reporting.Investigation summary: 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.

Event Description

Update: it was reported that the pfna was removed on (b)(6) 2020 because of a hematoma and abscess.

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: UNK - END CAPS: PFNA
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10601240
• MDR Text Key: 209018401
• Report Number: 8030965-2020-07513
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/09/2020
• Patient Sequence Number: 1
• Treatment: PFNA BLADE PERF L110 TAN; PFNA BLADE PERF L110 TAN; UNK - END CAPS: PFNA; UNK - NAILS: PFNA; UNK - NAILS: PFNA; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING
• Patient Outcome(s): Death