MAUDE Adverse Event Report: SYNTHES GMBH GUIDEWIRE ø1.1 L150 SST; GUIDE, SURGICAL, INSTRUMENT

Catalog Number	292.623S
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2023
Type of Reportable Event	Malfunction
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.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 depuy synthes reports an event in japan as follows: it was reported that on (b)(6) 2023, the patient underwent orif surgery for radial head fracture with guide wire.When the product in question was opened, it was found to be bent.The product in question was not used in surgery and the surgery was completed using another guidewire.Procedure was completed successfully without any surgical delay.No further information is available.This report is for one (1) 1.1mm non-threaded guide wire 150mm.This is report 1 of 1 for complaint (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H3, h6: a product investigation was conducted.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 guidewire ø1.1 l150 sst was found bent.No others problems were reported.A dimensional inspection was not performed for the guidewire ø1.1 l150 sst 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 excessive/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 ø1.1 l150 sst 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.H3, h6: device history record (dhr) review conducted: sterile part:292.623s; sterile lot no:117l446; release to warehouse date:16 dec, 2022; expiry date: 01 dec, 2032; manufacturing site: werk selzach; supplier: (b)(4).A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Part number: 292.623; lot number: 2600p63; manufacturing site: balsthal; release to warehouse date: 01.12.2022.A manufacturing record evaluation was performed for the finished device 292.623 lot number 2600p63, 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.

• Brand Name: GUIDEWIRE ø1.1 L150 SST
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach CO 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 17670254
• Report Number: 8030965-2023-11100
• Device Sequence Number: 7105068
• Product Code: FZX
• UDI-Device Identifier: 10886982180735
• UDI-Public: (01)10886982180735
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• 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

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
• Operator of Device: Health Professional
• Device Catalogue Number: 292.623S
• Device Lot Number: 117L446
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/18/2023
• Supplement Date Received by Manufacturer: 09/28/2023
• Initial Report FDA Received Date: 09/01/2023
• Supplement Report FDA Received Date: 10/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown