MAUDE Adverse Event Report: SYNTHES GMBH CONICAL EXTRACTION SCREW FOR 3.5MM SCREWS; EXTRACTOR

Catalog Number 309.521

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Initial reporter is a synthes sales representative.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 synthes (b)(6) reports an event as follows: it was reported piece of the extracting end of the extractor has broken off.This was discovered during inspection of the loan kit.This report is for an extractor.This is report 1 of 1 for pc-(b)(4).

Manufacturer Narrative

Product complaint # (b)(4).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.H10 additional narrative: d11: concomitant product added to complaint.E1: reporters state: (b)(6).H3, h4, h6: device history lot: part: 309.521, lot: 9469042, manufacturing site: bettlach, release to warehouse date: 29.June 2015.A manufacturing record evaluation was performed for the finished device lot number, and no non- conformances were identified.H6: investigation summary: investigation site: cq zuchwil.Selected flow: damage.Visual inspection: the device was found broken at the tip's threaded part.The broken part is missing.The observed damage is consistent with the reported complaint condition as such the complaint condition can be confirmed.All features related to the reported complaint condition were reviewed and no other issues were identified.Dimensional inspection: could not be performed due to post-manufacturing damage and the missing broken part.Document/specification review: the manufacturing review shows that the production procedure was according to the specifications and there were no issues that would contribute to this complaint condition.The review of the manufacturing documents has shown that with 1.4112 stainless steel the correct material was used and that the hardness was within the specification.Furthermore, according to inspection sheet (se_519889 version:ab), the thread area of this lot was inspected to 100% before the part left manufacturing site.Summary: the complaint can be confirmed based on the received condition of the device as well as with the picture provided by third party.This production lot (9469042) was manufactured in june 2015 according to the specification.This and the findings above let us exclude a manufacturing related issue.We do suppose that the device encountered unintended forces, such as being dropped on the floor and/ or excessive force application during its use, which finally resulted in the breakage.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition.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 3.5MM SCREWS
• Type of Device: EXTRACTOR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11073923
• MDR Text Key: 243781307
• Report Number: 8030965-2020-09973
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 07611819204409
• UDI-Public: (01)07611819204409
• 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: 11/27/2020

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: 309.521
• Device Lot Number: 9469042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Initial Date Manufacturer Received: 11/27/2020
• Initial Date FDA Received: 12/26/2020
• Supplement Dates Manufacturer Received: 01/11/2021
• Supplement Dates FDA Received: 01/28/2021
• Patient Sequence Number: 1
• Treatment: EXTRACTSCR F/SCR Ø3.5