MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PFNA-II BLADE L95 TAN; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 04.027.054S

Event Date 02/17/2018

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.No patient information available for reporting.Device is not considered implanted or explanted.Device has not been returned for investigation.(b)(6).Device is not distributed in the united states, but is similar to device marketed in the usa.Patient code is for prolonged sedation and change medical treatment plan.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 during a proximal femoral nailing (pfna ii) procedure to treat a trochanteric fracture on (b)(6) 2018, the impactor became stuck in the blade intraoperatively.The surgeon had successfully attached the pfna blade by counter-clock wise movement with its impactor and inserted the device.At the time of detaching the impactor, he found that it was not rotating clockwise, resulting in the impactor not being detached from the blade.As a result the surgeon removed the entire construct and used a dynamic hip screw (dhs) (which was there as a back-up support) to complete the surgery.A ninety (90) minute surgical delay was noted.This is report 1 of 2 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

Concomitant medical products: pfna-ii ø10 sm 130° l200 tan (part # 472.115s, lot # l626021, quantity 1).

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.

Manufacturer Narrative

Date device returned to manufacturer.A product investigation was conducted.We have received the blade and the impactor for investigation, upon visual inspection of the complaint devices it can be seen that the blade and the impactor are totally blocked together, this thus confirming the complaint description.Furthermore, the blade is showing signs of strong usage, and on the tip all four (4) lips are showing some damaged, also the surface has some long and deep scratches from implanting and explanting.In addition, the impactor is showing on the blue handle some dents and deformation, and at the distal end there it is broken and a broken of bit/part is missing.Dhr review of both showed no issues, which could lead to the complaint failure.No ncrs were marked in the dhr during production.Moreover, a review of our complaints data base shows, that there are no other complaints for this issue from this article and lot number.During investigation we have tried to separate the two parts, but it was not possible, not even when we really applied a lot of power.Based on the blocked parts a functional test is not possible.There is no particularize information what's happened to this articles by customer, unfortunately we are not able to determine the exact reason for this occurrence, but we have to assume that high applied mechanical force led to this damage and/or that during the operation an application error may have taken place.Based to the mentioned findings, no further investigation will be done.To prevent such problems, it is necessary to operate according to the technique guide.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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.Additional narrative: device history records review was completed for part# 04.027.054s, lot# l685123.Manufacturing location: bettlach, release to warehouse date: dec 08, 2017, expiry date: dec 01, 2027.No non- conformance reports were generated during production.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.Device was used for treatment, not diagnosis.If information is obtained t.

• Brand Name: PFNA-II BLADE L95 TAN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7353374
• MDR Text Key: 102947899
• Report Number: 8030965-2018-52242
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819394230
• UDI-Public: (01)07611819394230(17)EXPUNKNOWN(10)L685123
• 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,Followup,Followup
• Report Date: 02/21/2018

1 Device was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.027.054S
• Device Lot Number: L685123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2018
• Initial Date Manufacturer Received: 02/21/2018
• Initial Date FDA Received: 03/20/2018
• Supplement Dates Manufacturer Received: 04/04/2018; 04/25/2018; 05/14/2018; 05/30/2018
• Supplement Dates FDA Received: 04/18/2018; 05/11/2018; 05/17/2018; 05/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No