MAUDE Adverse Event Report: SYNTHES GMBH GUIDE WIRE 3.2MM FOR PFNA BLADE; GUIDE, SURGICAL, INSTRUMENT

Catalog Number	356.830
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/30/2023
Type of Reportable Event	Serious Injury
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, 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.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
Device report from synthes reports an event in japan as follows: it was reported that on (b)(6) 2023, the patient underwent open reduction/internal fixation surgery with the guide wire.When the surgeon inserted a blade, the guide wire penetrated the femoral head and also penetrated the acetabulum.After inserting the blade, the surgeon removed the guide wire, but the tip of the guide wire broke off and remained in the body.After the orif surgery was closed, at the senior surgeon¿s discretion, another surgeon was contacted, and this surgeon performed a laparotomy and removed the tip of the guidewire from the acetabular side.This was successfully removed without any damage to any organs.The surgery was prolonged by more than 120 minutes.The surgeon opined that the blade had been inserted without checking the images, which delayed the detection of the guidewire perforation.This report involves one guide wire 3.2mm for pfna blade.This is report 1 of 1 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.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.
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.H3, h4, h6 investigation summary 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 ø3.2 f/pfna blade had broken from the distal section of the rod, approximately 5.5 cm below the threaded tip.The fracture presents characteristic hints of unilateral and flexural stresses that might have been present during the extraction process.According to the femoral neck system surgical technique: "monitor the position of the wire during insertion and confirm the final position using the image intensifier.Over inserting guide wires could lead to damage to vital organs".The breakage condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces during insertion process.As it was reported that the guidewire ø3.2 f/pfna blade was over inserted.Ensuring proper handling of the device is recommended to avoid breakage in-situ.A dimensional inspection for the guidewire ø3.2 f/pfna blade was unable to be performed due to post manufacturing damage.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 ø3.2 f/pfna blade 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.Drawing/specifications reviewed? yes, reviewed.Dimensional inspection: n/a device history part #: 356.830 lot #: 4554p28 manufacturing site: balsthal release to warehouse date: 15.03.2023.A manufacturing record evaluation was performed for the finished device 356.830 lot #4554p28, and a reference to a non-conformance was found.The found non-conformance was created to correct the non-ppe documents in the routers at hägendorf and balsthal sites.This is not related to any manufacturing defect for device 356.830 lot #4554p28, and not related to the complaint condition described.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: GUIDE WIRE 3.2MM FOR PFNA BLADE
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): BALSTHAL; dornacherstrasse 20; balsthal CO 4710 ; SZ 4710
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 17746219
• Report Number: 8030965-2023-11573
• Device Sequence Number: 14818038
• Product Code: FZX
• UDI-Device Identifier: 10886982195623
• UDI-Public: (01)10886982195623
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: 356.830
• Device Lot Number: 4554P28
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/30/2023
• Supplement Date Received by Manufacturer: 09/25/2023; 11/09/2023
• Initial Report FDA Received Date: 09/14/2023
• Supplement Report FDA Received Date: 10/11/2023; 11/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female