MAUDE Adverse Event Report: SYNTHES GMBH EXTRACT-BOLT F/SCR Ø2.7; EXTRACTOR

Catalog Number	309.290
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 depuy synthes reports an event in japan as follows: it was reported that on an unknown date, the patient underwent the surgery for calcaneus with the va- calcaneal.Procedure was completed successfully without any surgical delay.After the surgery, removal surgery was performed on an unknown date.During the removal, it was confirmed, that the locking screw 2.7 in question had broken under the head.The surgeon tried extraction by the extraction bolt in question with a hollow reamer, but the extraction bolt idled without match on thread.The locking screw was pulled out using a vise grip by digging a little deeper in front bone.Procedure was completed successfully with thirty(30) minutes of surgical delay.The surgeon requested, that the threads inside the extraction bolt be checked for integrity.No further information is available.This report is for one (1) extraction bolt for 2.7mm screws.This is report 1 of 2 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.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 expected to be returned for manufacturer review/investigation, but has yet to be received.E3: reporter is a j&j employee.H3, h4, h6: without a lot number the device history records review could not be completed.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.
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.If information is obtained that was not available for this 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.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Part# 309.290 lot # 8771626 manufacturing site:werk bettlach release to warehouse date: 12 feb 2014 supplier: n/a expiration date: n/a.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that there were no damage or defect with the extract-bolt f/scr ø2.7, only was observed with signs of normal usage on all surface device, this condition does not affect the functionality of the device.A dimensional inspection for the extract-bolt f/scr ø2.7 was not performed as it is not applicable to the complaint condition.A functional test was unable to be performed due to mating device (screw) was not received to asses the interaction.The complaint condition was not able to be replicated.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed as the observed condition of the extract-bolt f/scr ø2.7 would not contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: EXTRACT-BOLT F/SCR Ø2.7
• Common Device Name: EXTRACTOR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BETTLACH; muracherstrasse 3; bettlach CO 2544 ; SZ 2544
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16845250
• Report Number: 8030965-2023-05475
• Device Sequence Number: 7516030
• Product Code: HWB
• UDI-Device Identifier: 07611819018365
• UDI-Public: (01)07611819018365
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup

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
• Operator of Device: Health Professional
• Device Catalogue Number: 309.290
• Device Lot Number: 8771626
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/12/2023
• Supplement Date Received by Manufacturer: 05/09/2023; 06/22/2023
• Initial Report FDA Received Date: 05/01/2023
• Supplement Report FDA Received Date: 05/23/2023; 07/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - REAMERS; UNK - SCREWS: 2.7 MM VA LOCKING
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown