MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH EXTRACTION SCREW FOR PFNA BLADE; EXTRACTOR

Catalog Number 03.010.411

Device Problem Device Difficult to Maintain (3134)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/11/2019

Event Type  malfunction  

Manufacturer Narrative

Additional pro-code: hxx.Device received.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.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 reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, during removal of an unknown proximal femoral nail antirotation (pfna) blade, the surgeon could not removed the blade from an extraction screw.There was no surgical delay and no patient harm reported.Surgical procedure outcome is unknown.Concomitant devices reported: unknown pfna nail (part# unknown, lot# unknown, quantity 1) and unknown locking screws (part# unknown, lot# unknown, quantity unknown).This complaint involves two (2) devices.This report is 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.A device history record (dhr) review was conducted: part: 03.010.411.Lot: 2586429.Manufacturing site: bettlach.Release to warehouse date: 17.Jun.2010.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.A product investigation was conducted.Visual inspection: upon visual inspection of the complaint device it can be seen that we have received the blade and the extractscr blocked to each other, this thus confirming the complaint description.The extractscr shows some signs of use (some scratches and dents), but otherwise the instrument is in a good condition.The blade is showing signs of usage all over the surface, and on the tip two (2) of the four (4) lips are showing deformation, and also the distal end of the implant got very strong deformation from pliers.Functional test: we have tried to separate those two parts, but this was not possible, based on this a functional test is not possible.Document/specification review: extractscr: a device history record (dhr) review was performed for the affected lot, 40 parts were delivered to the warehouse, no abnormalities or deviations were detected, which could lead to the complaint failure.The article was manufactured in june 2010.No ncrs were marked in the dhr during production.Drawings and revisions are in accordance to dhr of production lot.All relevant features are defined on the used drawing revisions of dhr of production lot.Blade: a device history record (dhr) review was performed for the affected lot, 50 parts were delivered to the warehouse, no abnormalities or deviations were detected, which could lead to the complaint failure.The article was manufactured in july 2017.No ncrs were marked in the dhr during production.Drawings and revisions are in accordance to dhr of production lot.All relevant features are defined on the used drawing revisions of dhr of production lot.Dimensional inspection: the investigation has shown that the cause of complained malfunction is a post-manufacturing caused use related damage at the device, therefore no dimensional inspection is needed.Furthermore the complaint relevant dimensions cannot be checked for dimensional accuracy, as we couldn¿t separate those parts from each other.Summary: there is no particularize information what's happened to this article by customer, unfortunately we are not able to determine the exact reason for this occurrence, but we have to assume that during the operation an application error may have taken place or/and that excessive force led to this damage.To prevent such problems, it is necessary worn or damaged instruments to replace and/or 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.

• Brand Name: EXTRACTION SCREW FOR PFNA BLADE
• Type of Device: EXTRACTOR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8571518
• MDR Text Key: 144718258
• Report Number: 8030965-2019-63374
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 07611819349483
• UDI-Public: (01)07611819349483
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 04/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.010.411
• Device Lot Number: 2586429
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2019
• Initial Date Manufacturer Received: 04/03/2019
• Initial Date FDA Received: 05/01/2019
• Supplement Dates Manufacturer Received: 05/23/2019
• Supplement Dates FDA Received: 06/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK - NAILS: PFNA; UNK - NAILS: PFNA; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING