MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PFNA Ø10 LONG R 130° L340 SST; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 272.280S

Device Problem Break (1069)

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

Patient height reported as 160.0 cms.Complainant part is not expected to be returned for manufacturer review/investigation.Device is not distributed in the united states, but is similar to device marketed in the usa.A review of the device history records has been requested.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 (b)(6) as follows: it was reported patient fell on (b)(6) 2018 resulting in an influx of a dislocated pertrochanteric and subtrochanteric femur fracture on the right, a subcapital humeral fracture on the right, and a distal radical fracture on the right.Patient was implanted with the proximal femoral nail antirotation (pfna) nail on the same day.X-rays taken on (b)(6) 2018 revealed that the nail was broken.Patient was returned to surgery on (b)(6) 2018 for removal of the broken device.It was further reported patient died on (b)(6) 2018.The patient died 4 days after the revision in the course of a fulminant postoperative ards.The revision was successful.The death is indirectly attributed to the pfna nail breakage, which necessitated the revision surgery placing the patient at additional medical risk.It is likely that the death was a result of the known comorbidities and age related infirmity and not related to the pfna malfunction itself.Concomitant devices reported: pfna blade (02.027.034s, lot l784517, quantity 1); locking screw (part number unknown, lot number unknown, quantity unknown); cable (part number unknown, lot number unknown, quantity unknown).This report is for one (1) pfna nail.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Dhr review was completed.Part: 272.280s.Lot: l740424.Manufacturing site: (b)(4).Release to warehouse date: 01.Feb.2018.Expiry date: 01.Jan.2028.The device history record shows this lot of 10 pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing process.The raw material certificate was reviewed and the used material was according to specification for implants for surgery.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.Customer quality conducted a review of the received x-ray.Clinical assessment states: the timeline of this patient¿s medical course speaks for itself.The information in this complaint record reasonably suggests that a device malfunction did occur and regardless of misuse, may have caused or contributed to a death.At the time of this review, the information available indicates the patient was initially implanted with pfna.Revision surgery was required 4 months due to a broken pfna nail.The revision surgery removing the broken pfna nail and inserting a proximal femoral plate was successfully completed.It was reported that the patient had multiple co-morbidities (osteoporosis, multiple embolic cerebral infarctions in the stromal area of the right cerebral artery, chronic anemia) and subsequently died 4 days after the revision surgery.The death is indirectly attributed to the pfna nail breakage, which necessitated the revision surgery placing the patient at additional medical risk.It is likely that the death was a result of the known comorbidities and age related infirmity and not related to the pfna malfunction itself.In addition, the proximal femoral plate and screws placed in at the successful revision surgery did not malfunction and did not cause or contribute to the ultimate death of this patient.The x-rays was reviewed and it can be confirmed that the pfna long is broken.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: the timeline of this patient¿s medical course speaks for itself.The information in this complaint record reasonably suggests that a device malfunction did occur and regardless of misuse, may have caused or contributed to a death.At the time of this review, the information available indicates the patient was initially implanted with pfna.Revision surgery was required 4 months due to a broken pfna nail.The revision surgery removing the broken pfna nail and inserting a proximal femoral plate was successfully completed.It was reported that the patient had multiple co-morbidities (osteoporosis, multiple embolic cerebral infarctions in the stromal area of the right cerebral artery, chronic anemia) and subsequently died 4 days after the revision surgery.The death is indirectly attributed to the pfna nail breakage, which necessitated the revision surgery placing the patient at additional medical risk.It is likely that the death was a result of the known comorbidities and age related infirmity and not related to the pfna malfunction itself.In addition, the proximal femoral plate and screws placed in at the successful revision surgery did not malfunction and did not cause or contribute to the ultimate death of this patient.The x-rays was reviewed and it can be confirmed that the pfna long is broken.Device history lot.Part: 272.280s.Lot:l740424.Manufacturing site: (b)(4).Release to warehouse date: (b)(6) 2018.Expiry date: 01.Jan.2028.The device history record shows this lot was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing process.The raw material certificate was reviewed and the used material was according to specification for implants for surgery.Review of the device history record showed that there were no issues during the manufacture of this product which 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: PFNA Ø10 LONG R 130° L340 SST
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7861632
• MDR Text Key: 119730529
• Report Number: 8030965-2018-56204
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 272.280S
• Device Lot Number: L740424
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/17/2019
• Patient Sequence Number: 1
• Treatment: SEE DESCRIPTION
• Patient Outcome(s): Death; Required Intervention
• Patient Weight: 70