MAUDE Adverse Event Report: SYNTHES GMBH CONICAL EXTRACTION SCREW FOR LARGE SCREWS & 4.9MM BOLTS; EXTRACTOR

Catalog Number	309.530
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2024
Type of Reportable Event	Malfunction
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.H11 additional narrative: 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.H11 additional narrative: corrected: d4 (primary udi number).H3, h4, h6: the product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device revealed that the tip of the extract-screw coni f/scr ø4.5+6.5 was found stripped.No other issues were observed, therefore, the reported condition can be confirmed.The observed condition was identified as an end of life indicator; damage consistent with repeated use and servicing.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 evaluation was not performed as it is not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the extract-screw coni f/scr ø4.5+6.5 would have contributed to the complained issue.Based on the investigation findings, the potential cause is traced to end of life, and it has been determined that no corrective and/or preventative action is required.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history review = > part# 309.530 lot # 2760627 manufacturing site: werk selzach logistik supplier:(b)(4).Release to warehouse date: 22 aug 2011 expiration date: na a manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified 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.H11 additional narrative: d9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.D4: udi: the expiration date is currently not available.As the serial number for the device involved in the event was not provided, the full udi is currently not available.E3: reporter is a j&j employee.H3, h4, h6: the product was not returned to depuy synthes, however photos were provided for review.The photo investigation revealed that 309.530, extract-screw coni f/scr ø4.5+6.5 has been stripped.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.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the extract-screw coni f/scr ø4.5+6.5 would contribute to the complained device issue.Based on the investigation findings, end of life and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history review (dhr): part# 309.530.Lot # 2760627.Manufacturing site: werk selzach logistik.Supplier: (b)(4).Release to warehouse date: 22 aug 2011.Expiration date: na.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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
It was reported that the tip of the instrument was burred off.This was identified by the loan kit technician during loan kit inspection on june 24, 2024.No further information was provided.This report involves one conical extraction screw for large screws & 4.9mm bolts this is report 1 of 1 for (b)(4).

• Brand Name: CONICAL EXTRACTION SCREW FOR LARGE SCREWS & 4.9MM BOLTS
• Common Device Name: EXTRACTOR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2425 ; SZ 2425
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 19766503
• Report Number: 8030965-2024-08849
• Device Sequence Number: 8514274
• Product Code: HWB
• UDI-Device Identifier: 07611819018457
• UDI-Public: (01)07611819018457(10)2760627
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 309.530
• Device Lot Number: 2760627
• 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: 06/24/2024
• Supplement Date Received by Manufacturer: 09/23/2024; 09/26/2024
• Initial Report FDA Received Date: 07/17/2024
• Supplement Report FDA Received Date: 09/25/2024; 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2011
• 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: EXTRACT-SCREW CONI F/SCR Ø4.5+6.5.
• Patient Sex: Unknown