MAUDE Adverse Event Report: SYNTHES GMBH DHS/DCS-GUIDEWIRE ø2.5 W/THREAD-TIP W/TR

Catalog Number 338.000S

Device Problem Entrapment of Device (1212)

Patient Problems Pain (1994); Foreign Body In Patient (2687)

Event Date 12/07/2023

Event Type  Injury  

Event Description

Device report from synthes reports an event in japan as follows: it was reported that the patient had a femoral trochanteric fracture on (b)(6) 2023, in france and underwent an unknown surgery on (b)(6) 2023, in france.After returning to japan, the patient complained of hip pain, so x-rays were taken, and it was discovered that a guidewire was stuck in the pelvis.On (b)(6) 2023, the guidewire was removed in a reoperation at hospital.The sales rep checked the medical record, and it stated that a synthes dhs had been used, but it was unable to confirm that it is j&j¿s product or not because the product code etc.Are unknown.The actual guidewire that was removed was checked and found to have threads at the tip, and it is assumed to be the dhs/dcs-guidewire.No further information is available.This report is for one (1) dhs/dcs-guidewire ã¸2.5 w/thread-tip w/tr.This is report 1 of 1 for complaint (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.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.

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.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 the tip of the dhs/dcs-guidewire ã¸2.5 w/thread-tip w/tr was broken off.Only a fragment was received and according to the pictures provided belongs to guidewire that was stuck in the pelvis of the patient.A dimensional inspection for the dhs/dcs-guidewire ã¸2.5 w/thread-tip w/tr was not performed due to post manufacturing damage.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 based on the photos provided.The observed condition of the dhs/dcs-guidewire ã¸2.5 w/thread-tip w/tr 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.An x-ray was also provided for review, the x-ray investigation revealed that a small piece of a device is seen in the x-ray.The component was explanted and does not have a product code etch but bears resemblance to dhs/dcs-guidewire 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: DHS/DCS-GUIDEWIRE ø2.5 W/THREAD-TIP W/TR
• Type of Device: GUIDE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18578821
• MDR Text Key: 333668559
• Report Number: 8030965-2024-01315
• Device Sequence Number: 1
• Product Code: FZX
• UDI-Device Identifier: 07611819898837
• UDI-Public: (01)07611819898837
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 338.000S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female