MAUDE Adverse Event Report: SYNTHES GMBH EXTRACTION BOLT FOR 3.5MM & 4.0MM SCREWS; EXTRACTOR

Catalog Number	309.039
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from synthes reports an event in canada as follows: it was reported that before surgery, the drill bits were identified as dysfunctional by a staff member; no case was impacted.Device interaction issues, felt a grinding when bit was passed through guide.There were no patient outcomes or consequences.This report is for one (1) extraction bolt for 3.5mm & 4.0mm screws this is report 1 of 1 for complaint (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j sales representative.H3, h4, h6: without a lot number the device history records review could not be completed.Product was not returned.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.
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.H3, h4, h6: part: 309.039, lot: 2725374, manufacturing site: werk selzach logistik, supplier: (b)(4), release to warehouse date: 01 june 2011, expiration date: na.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.The device associated with this report was returned to depuy synthes for evaluation.Visual analysis of the device found the inner threads from the distal tip stripped, the overall device has a worn appearance.Assembly issues are most likely due to this condition.The observed condition was consistent as an end of life indicator for the device.No other issues were identified.The device exhibits damage consistent with repeated use.The lifecycle requirements of the device are event related and depend on the use and inspection of the device in clinical practice.As the device can be damaged on the first or 100th use, the device must be properly inspected prior to each surgical use.Refer to the device/country specific ifu for information related to end of life, reprocessing instructions, and inspection procedures.A dimensional inspection was not performed as it is not applicable to the complaint condition.A functional test was not performed as it is not applicable to complaint condition.The overall complaint was confirmed as the observed condition of the extract-bolt f/scr ø3.5+4 would contribute to the complained issue.There is no indication that a design or manufacturing issue has caused the complaint condition.It was determined that the reusable instrument was worn from repeated use and servicing.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.Drawing/specifications reviewed the drawings reflecting the current and manufactured revisions were reviewed.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 3.5MM & 4.0MM SCREWS
• Common Device Name: EXTRACTOR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach CO 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18138915
• Report Number: 8030965-2023-14351
• Device Sequence Number: 12374316
• Product Code: HWB
• UDI-Device Identifier: 07611819056503
• UDI-Public: (01)07611819056503
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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: 309.039
• Device Lot Number: 2725374
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/20/2023
• Supplement Date Received by Manufacturer: 11/16/2023
• Initial Report FDA Received Date: 11/15/2023
• Supplement Report FDA Received Date: 12/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2011
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2.5MM DRILL BIT/QC/GOLD/110MM; 6MM/9MM CANNULATED STEPPED DRILL BIT
• Patient Sex: Unknown