MAUDE Adverse Event Report: SYNTHES GMBH 2.8MM THREADED GUIDE WIRE- TROCAR POINT 300MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number 292.680

Device Problem Break (1069)

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

Event Date 10/12/2022

Event Type  malfunction  

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.Additional narrative: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.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.

Event Description

Device report from synthes reports an event in colombia as follows: guide needle is used to perform reduction, needle is broken, without patient impact, no fragments remained in patient.This report is for one (1) guidewire ø2.8 w/thread-tip w/trocar l30 this is report 1 of 1 for complaint pc-(b)(4).

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.H11: corrected data-d9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h6: 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.Lot # provided is not a valid number, therefore, the dhr could not be completed.If device is returned or lot number can be confirmed, the dhr will be revisited.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: a manufacturing record evaluation was performed for the finished device 292.680 lot #769p078, and no non-conformances were identified.Part #: 292.680.Lot #: 769p078.Manufacturing site: balsthal.Release to warehouse date: 22-apr-2022.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 guidewire ø2.8 w/thread-tip w/trocar l30 was broken from the threaded tip.The broken fragment was returned for examination.No other issues were found.A dimensional inspection for the guidewire ø2.8 w/thread-tip w/trocar l30 was not performed as is not applicable to the complaint condition.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the guidewire ø2.8 w/thread-tip w/trocar l30 would 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.

Manufacturer Narrative

No conclusions could be drawn as no devices were returned for manufacturer review or investigation.Additionally, device history record reviews could not be requested as specific part and lot numbers for the associated devices were not provided.Additional narrative: e1: phone number reported as (b)(6) no conclusions could be drawn as no devices were returned for manufacturer review or investigation.Review of manufacturing records has been requested.D1, d4 d7: it is unknown if this single-use device was reprocessed and reused.

• Brand Name: 2.8MM THREADED GUIDE WIRE- TROCAR POINT 300MM
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BALSTHAL; dornacherstrasse 20; balsthal NY 4710 ; SZ 4710
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15718484
• MDR Text Key: 307183472
• Report Number: 8030965-2022-09256
• Device Sequence Number: 1
• Product Code: LXT
• UDI-Device Identifier: 07611819065208
• UDI-Public: (01)07611819065208
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 292.680
• Device Lot Number: 769P078
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female