MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PFNA-II BLADE L100 TAN; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.027.055S

Device Problem Break (1069)

Patient Problems Blood Loss (2597); Not Applicable (3189)

Event Date 01/11/2019

Event Type  Injury  

Manufacturer Narrative

Device is not distributed in the united states, but is similar to device marketed in the usa.The device was received, and the product evaluation is in progress.No conclusion can be drawn.Additionally, device history records review 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 europe reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, during an open reduction internal fixation surgery with proximal femoral nail antirotation (pfna), the pfna ii helical blade suddenly stopped when inserted and could not be inserted further or extracted from the bone.The surgeon once locked the helical blade and removed it using an extraction screw for pfna blade.The helical blade broke during the removal because an extraction screw held the helical blade tightly.The surgery was completed successfully by inserting another helical blade.The surgery was delayed by less than 30 minutes.There was an unscheduled bleeding caused by blade extraction during the surgery.Upon the preliminary inspection of the received devices at the manufacturer, it was noted that the tip of the extractor f/pfna blade was broken off and not the pfna blad as initially reported.Concomitant medical products: pfna ii nail (part unknown, lot unknown, quantity 1), locking screw (part unknown, 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.Visual inspection: the received implant is in bad and very used condition and it is clearly visible that excessive force was applied onto the part.The surface of the blade shows a lot of wear marks.Additionally the end cap stuck into the sleeve in a twisted position.These are clear indication that a lot of force was applied during use.Functional test: a functional test could not be performed as the item is completely stuck and damaged.Dimensional inspection: because of the damages the complaint relevant dimensions cannot be checked to print specifications anymore.Drawing/specification review: the investigation has shown that the cause of complained malfunction is a post-manufacturing caused use related damage at the device, therefore no drawing/specification review is needed.Summary: the received implant is in bad and very used condition and it is clearly visible that excessive force was applied onto the part.The surface of the blade shows a lot of wear marks.Additionally the end cap stuck into the sleeve in a twisted position.These are clear indication that a lot of force was applied during use.The device history record was researched, no abnormal findings were identified.There were no issues during the manufacturing of the product that would contribute to this complaint condition.Additionally these instruments underwent a functional inspection before leaving the plant.This lot of 40 pieces was manufactured in december 2015 according to the specification.Based on that and the condition of the item a product related issue can be excluded.Unfortunately we are unable to determine the exact cause which has led to this occurrence.Based on the strong damages on the pfna blade we must assume that a mechanical overloading situation has caused problem.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.Device history lot, part: 04.027.055s, lot: 9760516, manufacturing site: bettlach, release to warehouse date: 17.Dec.2015, expiry date: 01.Dec.2025.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.The complete pfna-ii blade 04.027.055s was made from following sub-components: 60041007 pfna-ii blade; lot 9609423 made from raw material 18848.60041013 pfna-ii sleeve; lot 9678637 made from raw material 18451.60041015 end cap; lot 9691861 made from raw material 18839.60026322 pfna screw; lot 9642498 made from raw material 18633.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-II BLADE L100 TAN
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8293659
• MDR Text Key: 134624820
• Report Number: 8030965-2019-60529
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819394247
• UDI-Public: (01)07611819394247
• 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: 01/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.027.055S
• Device Lot Number: 9760516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2019
• Date Manufacturer Received: 02/27/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR