MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PFNA-II BLADE L90 TAN; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.027.053S

Device Problems Difficult to Remove (1528); Material Protrusion/Extrusion (2979)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 12/19/2019

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Pma/510k: 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.(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) 2019 the patient underwent surgery with the proximal femoral nail antirotation (pfna), the incision was closed with the blade protruding (reported by (b)(4)).On (b)(6) 2019 the patient underwent removal surgery.The surgeon tried another removal method which had not been performed in the first surgery but the blade could not be removed.The surgeon cut the blade with a cutting tool and the surgery was completed successfully with more than 30 minutes delay.The removal surgery could relieve the patient¿s pain.There was no plan to perform the revision surgery.No further information is available.Concomitant devices: unknown end caps ( part# unknown, lot# unknown, quantity 1), unknown locking screw ( part# unknown, lot# unknown, quantity unknown).This report is for one pfna-ii nail.This is report 2 of 2 for (b)(4).This report is linked to (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.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 history part: 04.027.053s, lot: 5l85102, manufacturing site: bettlach, release to warehouse date: 30.Aug.2019, expiry date: 01.Aug.2029.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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-II BLADE L90 TAN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9587936
• MDR Text Key: 175089112
• Report Number: 8030965-2020-00364
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819394223
• UDI-Public: (01)07611819394223
• 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
• Report Date: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.027.053S
• Device Lot Number: 5L85102
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/16/2020
• Patient Sequence Number: 1
• Treatment: UNK - END CAPS: PFNA-II; UNK - SCREWS: LOCKING
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR