MAUDE Adverse Event Report: HAGENDORF SYNTHES PRODUKTIONS GMBH WIRE GUIDE / MULTIHOLE / LG NL 8-11; GUIDE, SURGICAL, INSTRUMENT

Model Number	03.043.005
Medical Device Problem Code	Material Deformation (2976)
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
It was reported that, the tip was bent in one of the cannulas not allowing a wire to pass through it.This report is for one (1) wire guide / multihole / lg nl 8-11.This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Occupation: reporter is a j&j sales representative.Without a lot number the device history records review could not be completed.Product was not returned.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.
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.B3: date of event is an unknown date in 2021.H3, h4, h6: part: 03.043.005, lot: 142p757, manufacturing site: haegendorf, release to warehouse date: april 30, 2021.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the wire guide / multihole / lg nl 8-11 was received at us customer quality (cq).Visual inspection of the complaint device showed one of the guide wire hollows was deformed.No other issues were observed with the complaint device.Dimensional inspection: a relevant dimensional inspection was not able to perform due to the device geometry.Document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed.-wire guide, for nails ø8-11mm no design issues or discrepancies were identified.Investigation conclusion: this complaint is confirmed as one of the guide wire hollows was deformed.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.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 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: WIRE GUIDE / MULTIHOLE / LG NL 8-11
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): HAGENDORF SYNTHES PRODUKTIONS GMBH; im bifang 6; hagendorf 4614 ; SZ 4614
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13258434
• Report Number: 8030965-2022-00344
• Device Sequence Number: 4760762
• Product Code: FZX
• UDI-Device Identifier: 10886982297150
• UDI-Public: (01)10886982297150
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• 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: 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 Model Number: 03.043.005
• Device Catalogue Number: 03.043.005
• Device Lot Number: 142P757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/20/2021
• Supplement Date Received by Manufacturer: 01/27/2022
• Initial Report FDA Received Date: 01/14/2022
• Supplement Report FDA Received Date: 02/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2021
• 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: UNK - CABLE/WIRE
• Patient Sex: Unknown