MAUDE Adverse Event Report: SYNTHES GMBH 4.5MM TI CORTEX SCREW SELF-TAPPING 26MM; PLATE, FIXATION, BONE

Catalog Number 414.826

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 09/15/2022

Event Type  malfunction  

Manufacturer Narrative

Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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.Additional narrative: additional product codes: hwc, ktt.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a j&j sales representative.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 Description

Device report from synthese reports an event in italy as follows: it reported on (b)(6) 2022 that the envelope package was empty and no product inside.No patient impact.This report is for one (1) cortscr ø4.5 self-tap l26 ti.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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: a manufacturing record evaluation was performed for the finished device lot, and no non-conformance's were identified.Part number: 414.826 lot number: 1436p39 manufacturing site: (b)(4).Release to warehouse date: 22 august 2022 the product was returned to depuy synthese for evaluation.The depuy synthese team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the cortscr ø4.5 self-tap l26 ti was found package empty.The package arrives open, the complaint cannot be confirmed as there is no evidence when the package was compromised.No other defect was found.A dimensional inspection for the cortscr ø4.5 self-tap l26 ti was unable to be performed since it was not applicable to the complaint condition.As part of depuy synthese quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed as the cortscr ø4.5 self-tap l26 ti.No definitive root cause could be determined.There was no indication that a design or manufacturing issue contributed to the 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.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.

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, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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.

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.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: 4.5MM TI CORTEX SCREW SELF-TAPPING 26MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15615668
• MDR Text Key: 306708295
• Report Number: 8030965-2022-08254
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819200982
• UDI-Public: (01)07611819200982
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K112583
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,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
• Device Operator: Health Professional
• Device Catalogue Number: 414.826
• Device Lot Number: 1436P39
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/26/2022
• Initial Date FDA Received: 10/17/2022
• Supplement Dates Manufacturer Received: 10/20/2022; 11/14/2022; 12/15/2022
• Supplement Dates FDA Received: 11/10/2022; 12/08/2022; 12/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1