MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH CONICAL EXTRACTION SCREW FOR 2.7MM & 3.5MM CORTEX SCREWS; EXTRACTOR

Catalog Number 309.52

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Reporter is a synthes employee.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 (b)(6) reports an event as follows: it was reported on an unknown date by the loan kit technician during a loan kit inspection that the extracting end of the conical extraction screw for 2.7mm & 3.5mm cortex screw and the extraction bolt for 2.0mm screws have snapped off.This report is for one (1) conical extraction screw for 2.7mm & 3.5mm cortex screws 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.H3, h6: part: 309.520, lot: 9739692, manufacturing site: bettlach, release to warehouse date: 11.January 2016.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the threaded tip of the extraction screw is broken off as complained.Approx.1.5mm of the conical threaded tip section are missing, the broken off part was not returned for investigation.The fracture angle is oblique.Besides, the instrument presents normal signs of use.Dimensional inspection: total length of extraction screw failed, due to breakage.Further dimensional inspection cannot be performed due to the damage incurred.Document/specification review: the review has shown that with 1.4112 stainless steel the correct material was used, and that the hardness was within the specification.Summary the complaint condition is confirmed as the tip of the extraction screw is broken.This production lot (9739692) was manufactured in january 2016 according to the specification.The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements with no non-conformities reported.The correct material was used, and the hardness parameters were within the specifications.There were no issues during the manufacture of this product that would contribute to this complaint condition.The damage occurred is determined to be post production/acceptance criterias.Based on the provided information ¿ damage noted during loan kit inspection - we are not able to determine the exact cause of this occurrence.However, the oblique fracture angle suggests that off-axis force has been applied.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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: CONICAL EXTRACTION SCREW FOR 2.7MM & 3.5MM CORTEX SCREWS
• Type of Device: EXTRACTOR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10356989
• MDR Text Key: 201702411
• Report Number: 8030965-2020-05562
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 07611819018440
• UDI-Public: 07611819018440
• 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: 07/10/2020

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: 309.52
• Device Lot Number: 9739692
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2020
• Initial Date Manufacturer Received: 07/11/2020
• Initial Date FDA Received: 08/03/2020
• Supplement Dates Manufacturer Received: 08/11/2020
• Supplement Dates FDA Received: 09/08/2020
• Patient Sequence Number: 1