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

Catalog Number 03.010.411

Device Problem Break (1069)

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

Event Date 01/11/2019

Event Type  Injury  

Manufacturer Narrative

Additional device procode: hxx.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 extract screw for blade was broken off and not the pfna blade as initially reported.Concomitant devices: pfna ii nail (part unknown, lot unknown, quantity 1); locking screw (part unknown, lot unknown, quantity 1).This report is for one (1) extraction screw for pfna blade.This is report 2 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Visual inspection: the visual inspection of the returned item has shown that the tip section with the threaded part and the hex is completely broken off.The broken tip section stuck into the returned pfna blade.The extraction screw is in used condition and shows wear marks on the surface of the whole instrument.Dimensional inspection: due to the damages the relevant dimension could not be measured.However the parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements.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.Material review: 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.Summary: the received condition of the extraction screw is concordant with the complaint description and the complaint condition is confirmed.This lot was manufactured in february 2016 according to the specification.Based on that and the condition of the item a product related issue can be excluded.Unfortunately we are not able to determine the exact cause which has led to this occurrence.Based on the strong damages on the extraction screw and the pfna blade we must assume that a mechanical overloading situation has caused the breakage.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: 03.010.411 lot: 9817717 manufacturing site: bettlach release to warehouse date: 05.Feb.2016 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 criteria at the time of release with no issues documented during the manufacturing process.Only top level of the device history record reviewed as sub-components are not lot tracked.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: 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: 8293660
• MDR Text Key: 134626069
• Report Number: 8030965-2019-60531
• 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: 01/11/2019

1 Device was Involved in the Event

1 Patient 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: 03.010.411
• Device Lot Number: 9817717
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2019
• Initial Date Manufacturer Received: 01/11/2019
• Initial Date FDA Received: 01/31/2019
• Supplement Dates Manufacturer Received: 02/27/2019
• Supplement Dates FDA Received: 03/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR