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

Catalog Number 04.027.053S

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/06/2018

Event Type  malfunction  

Manufacturer Narrative

Device 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.Device history records review was completed for part: 04.027.053s, lot: 1l44164.Manufacturing location: (b)(4), release to warehouse date: sep 19, 2018, expiry date: sep 01, 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, visual and functional criteria at the time of release with no issues documented during the manufacturing process.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Product was not returned.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.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 on (b)(6) 2018, the patient had a proximal femoral nail antirotation (pfna) system due to femoral trochanteric fractures.While attaching the pfna blade on the impactor, it was hard to unlock the blade since it had been locked too tightly.It took more than 10 minutes to unlock the blade.The surgeon was sure that the impactor was rotated to the counterclockwise direction, and used a key for pfna blade.After several attempts trying to unlock the blade, they finally succeeded.Once the blade was unlocked, the impactor was attached to the blade properly.And the blade was properly locked inside the patient¿s body.There was a surgical delay of thirty (30) minutes.Procedure outcome is unknown.There was no adverse consequence to the patient.Concomitant device: key for pfna blade (part: 356.832, lot: unknown, quantity: 1).This report is for one (1) pfna blade.This is report 1 of 2 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.Explant date: device has not been explanted.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: 8103674
• MDR Text Key: 128390648
• Report Number: 8030965-2018-58468
• 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: 11/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.027.053S
• Device Lot Number: 1L44164
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/09/2019
• Patient Sequence Number: 1