MAUDE Adverse Event Report: SYNTHES GMBH GUIDEWIRE ø1.6 L220 SST; PIN, FIXATION, SMOOTH

Catalog Number 02.226.001S

Device Problems Tear, Rip or Hole in Device Packaging (2385); Material Deformation (2976)

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

Event Date 12/11/2023

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).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.E1: (b)(6).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 Description

Device report from synthes reports an event in japan as follows: it was reported that on (b)(6) 2023, the patient underwent the ankle joint fixation with the guide wires for the distal tibia.When the surgeon opened the package, the guide wire was deformed.Although a new package was opened, the guide wire was also deformed.Both outer boxes had scratches on them.The third guide wire was used for surgery.The surgery was completed successfully without any surgical delay.No further information is available.This report is for one (1) guidewire ã¸1.6 l220 sst.This is report 1 of 2 for (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.H3,h4,h6 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 device had found bent from the shaft.The package arrived opened.There is not enough evidence to confirmed damage of the packing.No other defect was found.A dimensional inspection for the returned sample was unable to be performed due to post manufacturing damage.The overall complaint was confirmed as the observed condition of the guidewire ã¸1.6 l220 sst would contribute to the complained device issue.Based on the investigation findings, 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 reported 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.The following drawings reflecting the current and manufactured revisions were reviewed: se_192339 rev.B (current and manufactured) dimensional inspection: n/a h4,h6 part # 02.226.001s, lot # 190l840, manufacturing site: werk selzach, release to warehouse date: 14.Jun.2023, expiration date: 01.Jun.2033, supplier: (b)(4).A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Part #: 02.226.001, lot #: 5416p22, manufacturing site: balsthal, release to warehouse date: 04-mai-2023.A manufacturing record evaluation was performed for the finished device 02.226.001 lot # 5416p22, 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.

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: h3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: GUIDEWIRE ø1.6 L220 SST
• Type of Device: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK SELZACH; bohnackerweg 5; selzach CO 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18442973
• MDR Text Key: 331942218
• Report Number: 8030965-2024-00198
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 10886982057655
• UDI-Public: (01)10886982057655
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K080943
• 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
• Report Date: 01/03/2024

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: 02.226.001S
• Device Lot Number: 190L840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2023
• Initial Date FDA Received: 01/04/2024
• Supplement Dates Manufacturer Received: 01/24/2024; 03/04/2024
• Supplement Dates FDA Received: 02/06/2024; 03/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: GUIDEWIRE ø1.6 L220 SST