MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 13.0MM/3.2MM WIRE GUIDE FOR SPIRAL BLADE AIMING ARM

Model Number	03.010.082
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.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.Without a lot number the device history records review could not be completed.Product was not returned.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
It was reported that on an unknown date, the correct guide wire for spiral blade aiming arm would not fit through the protection drill sleeve.It is unknown how the issue was discovered.It is unknown if there were surgical involvement.No patient consequences.This report is for 1 of 2 for (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.H10 additional narrative: d4: lot number; d10.H3, h6: a product investigation was conducted.Visual inspection: the 13.0 mm /3.2 mm wire guide for spiral blade aiming arm (part # 03.010.082, lot # 1756847, mfg # 17-oct-2007) was received at us cq with the wire guide inserted into the protection sleeve (part # 03.010.081, lot # 3057633.) there was no damage on the device.Functional test: a functional test was performed, and the wire guide was able to be disassembled from the protection sleeve and then re-assembled.This is not consistent with the reported complaint condition and the complaint was not able to be replicated.Therefore, the complaint is not confirmed.Dimensional inspection: dimensional analysis was completed, the inner diameter of the shaft, measured and is within specification based on relevant drawing.The outer diameter of the shaft measured and is within specification based on relevant drawing.Document/specification review: the relevant drawing(s) was reviewed; conclusion: there is no indication that a design or manufacturing issue contributed to the complaint.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.No new malfunctions were observed during the course of this investigation.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.H3, h4, h6: a device history record (dhr) review was conducted: part: 03.010.082; lot: 1756847; manufacturing site: hägendorf; release to warehouse date: 17.Oct.2007.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: 13.0MM/3.2MM WIRE GUIDE FOR SPIRAL BLADE AIMING ARM
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9208436
• Report Number: 2939274-2019-61655
• Device Sequence Number: 3031514
• Product Code: FZX
• UDI-Device Identifier: 10886982067524
• UDI-Public: (01)10886982067524
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2019

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: 03.010.082
• Device Catalogue Number: 03.010.082
• Device Lot Number: 1756847
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2019
• Initial Date Received by Manufacturer: 10/02/2019
• Supplement Date Received by Manufacturer: 10/23/2019
• Initial Report FDA Received Date: 10/18/2019
• Supplement Report FDA Received Date: 11/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1