MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH EXTRACTION BOLT FOR 2.0MM SCREWS; EXTRACTOR

Catalog Number	309.190
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a synthes employee.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 or Problem Description
Device report from (b)(6) reports an event as follows: it was reported that on an unknown date it was found that a piece has snapped off inside the threaded area of the extraction bolt.This report is for one (1) extraction bolt for 2.0mm screws.This is report 1 of 1 for (b)(4).
Additional 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 product investigation was conducted.Pre-investigation statement: visual inspection performed at customer quality (cq) identified that the extraction bolt is intact (not broken) but a portion of an unknown broken screw is still jammed inside the extraction bolt.Hence, the investigation flow ¿device interaction-functional¿ was chosen.Visual inspection: visual inspection performed at customer quality (cq) identified that a portion of an unknown broken screw is still jammed inside the extraction bolt.The extraction bolt is intact and presents only minor signs of use.Functional test: cannot be performed due to the damage incurred.Dimensional inspection: cannot be performed due to the damage incurred.The jammed screw-portion could not be disassembled from extraction bolt.Document/specification review: the extraction bolt was manufactured in september 2018 according to the specifications.The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements.The relevant documents were reviewed as part of this investigation: the review has shown that with 1.4112 stainless steel the correct material was used, and that the hardness was within the specification of 650 ¿ 730 hv0.5 summary: the complaint condition is confirmed for the functional issue as a portion of an unknown screw is still blocked in the extraction bolt.But the extraction bolt is not broken.This production lot (l945320) was manufactured 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.Based on the provided information we are not able to determine a potential cause of this complaint.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.A device history record (dhr) review was conducted: part: 309.190, lot: l945320, manufacturing site: bettlach, release to warehouse date: 11.Sep.2018/ a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Date rec¿d by mfr : the incorrect date was inadvertently utilized in initial medwatch.The correct date is november 13, 2019.  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 BOLT FOR 2.0MM SCREWS
• Common Device Name: EXTRACTOR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9413327
• Report Number: 8030965-2019-70764
• Device Sequence Number: 16877529
• Product Code: HWB
• UDI-Device Identifier: 07611819018310
• UDI-Public: (01)07611819018310
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 309.190
• Device Lot Number: L945320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2019
• Initial Date Received by Manufacturer: 11/14/2019
• Supplement Date Received by Manufacturer: 12/03/2019
• Initial Report FDA Received Date: 12/04/2019
• Supplement Report FDA Received Date: 12/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1