MAUDE Adverse Event Report: SYNTHES GMBH AIM-DEVICE F/GUIDEWIRE F/PFNA+TFN F/AP O; GUIDE, SURGICAL, INSTRUMENT

Catalog Number	03.010.412
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that, the surface of the product had begun to crack.No patient involvement.This report is for one (1) aim-device f/guidewire f/pfna+tfn f/ap o.This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
If the information is unknown, not available or does not apply, the section/field of the form is left blank.A device history record (dhr) review was conducted: visual inspection: the complaint device (aim-device f/guidewire f/pfna+tfn f/ap o) was returned for investigation.Additionally, a photo in the notes & attachments section was reviewed.It was identified cracked and broken sections of the epoxy covering across the middle section of the wire surface; the photo findings are consistent with physical investigation.No other issues were identified.Dimensional inspection: a dimensional inspection could not be performed as the device has post manufacturing damage and complex geometry; relevant dimensions cannot be measured.Document/specification review: the current drawings were reviewed.Investigation conclusion: the reported condition of the complaint device (aim-device f/guidewire f/pfna+tfn f/ap o) is confirmed.After investigation, the cracking condition is visible, but there are chipped details at the middle section of the device.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/ specification review.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.Device history lot - a manufacturing record evaluation was performed for the finished device lot number, 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: AIM-DEVICE F/GUIDEWIRE F/PFNA+TFN F/AP O
• 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 2545 ; SZ 2545
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13285469
• Report Number: 8030965-2022-00378
• Device Sequence Number: 20060743
• Product Code: FZX
• UDI-Device Identifier: 07611819349490
• UDI-Public: (01)07611819349490
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 03.010.412
• Device Lot Number: 13F6968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/10/2022
• Initial Report FDA Received Date: 01/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2013
• 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
• Patient Sex: Unknown