MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PFNA Ø10 LONG R 130° L380 SST; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 272.295S

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

It is unknown if the complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Device is not distributed in the united states, but is similar to device marketed in the usa.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.A review of the device history records has been requested.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 (b)(4) reports an event as follows: it was reported that on (b)(6), 2018, a proximal femoral nail anti-rotation (pfna) nail broke on a walk.Initially, the pfna nail was implanted on (b)(6) 2018.The patient underwent a revision on (b)(6) 2018.It is unknown how the procedure was completed.Patient outcome is unknown.Concomitant devices: locking screw (part/lot unknown, quantity 1); pfna blade (part/lot unknown, quantity 1).This report is for a pfna nail.This is report 1 of 1 for (b)(4).

Manufacturer 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.

Event Description

After the revision surgery, the patient was weakened with more pain than they experienced after the first operation.The recuperation also took longer.

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.Part: 272.295s; lot: l546915; manufacturing site: bettlach; release to warehouse date: september 06, 2017; expiry date: august 01, 2017 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 l393829 was reviewed and the used material was according to iso-5832-1 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.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: PFNA Ø10 LONG R 130° L380 SST
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8126303
• MDR Text Key: 129148371
• Report Number: 8030965-2018-58711
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819191488
• UDI-Public: (01)07611819191488
• 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: 11/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2017
• Device Catalogue Number: 272.295S
• Device Lot Number: L546915
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/05/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR