MAUDE Adverse Event Report: SYNTHES GMBH GUIDEWIRE Ø3.2 F/PFNA BLADE; GUIDE, SURGICAL, INSTRUMENT

Catalog Number	356.83
Medical Device Problem Codes	Entrapment of Device (1212); Material Deformation (2976)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/23/2022
Type of Reportable Event	Serious Injury
Additional 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.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).Investigation summary.Photo investigation: the photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned attachments.Visual analysis of the photo revealed that there was no damage or defects with the guidewire ø3.2 f/pfna blade.The quality of x -ray provided is not the indicated to determine the allegations reported.No other problems were observed.Conclusion: the complaint condition is being confirmed during photo/video investigation.During the investigation, no product design issues or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.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 singapore as follows: it was reported that on (b)(6) 2022, during a the trochanteric fixation nail - advanced (tfna) case, 356.830_0761819291355 was inserted into the femoral head, and drill bit stepped ream f/tfna helic blade+scr f/dh was guided into the 356.830 to drill.It was met with resistance halfway through.The surgeon tried to push in and continue with the drilling, but still met with resistance.An x-ray showed stepped ream f/tfna helic blade+scr f/dh was cutting on the guidewire ø3.2 f/pfna blade, and the guidewire ø3.2 f/pfna blade appear bent.Stepped ream f/tfna helic blade+scr f/dh was removed, and found no damage to the drill bit guidewire ø3.2 f/pfna blade was removed, and metal particles could be seen left inside the femoral head.Surgeon tried to flush out the metal particles, there were still metal particle left inside the femoral head.The surgeon change to another wire and continue with the surgery.No patient consequence was reported.Surgery was delayed 5 minutes due to reported issue.This report is for one (1) guidewire ø3.2 f/pfna blade.This is report 1 of 2 for complaint product complaint (b)(4).

• Brand Name: GUIDEWIRE Ø3.2 F/PFNA BLADE
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15077011
• Report Number: 8030965-2022-05062
• Device Sequence Number: 14827970
• Product Code: FZX
• UDI-Device Identifier: 07611819291355
• UDI-Public: (01)07611819291355
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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
• Report Date (Section B): 07/21/2022

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: 356.83
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/23/2022
• Initial Report FDA Received Date: 07/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: STEPPED REAM F/TFNA HELIC BLADE+SCR F/DH
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female