MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC INSERTION GUIDE

Model Number	323.050
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is synthes sales representative.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.Device was used for treatment, not diagnosis.If additional information is made available, the investigation will be updated as applicable.
Event or Problem Description
It was reported that on an unknown date, while inspecting the instruments after going through the decontamination process, it was discovered that some instruments were damaged.The star drive screwdriver shaft is bent and wobbles in the screwdriver handle, wire guide sleeve won't fully insert into the blade guide, blade/screw guide sleeve will not let the blade inserter engage the rifling properly, tube part of depth gauge for screws is bent and will not let the screw down piece engage the threads, the insertion guide was bent and the sleeves were unable to be inserted full.However, it was set aside and inadvertently placed in the sharps container by the staff and was unable to be retrieved.There was no patient involvement with any of these items.This complaint involves five (5) devices.Concomitant products: depth gauge for screws ø 2.7 to 4.0 mm, measuring range up to 60 mm, 3.2mm wire guide sleeve, blade/screw guide sleeve, depth gauge for screws ø 2.7 to 4.0 mm, insertion guide.This report is for one (1) insertion guide.This report is 5 of 5 for (b)(4).

• Brand Name: INSERTION GUIDE
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11252022
• Report Number: 2939274-2021-00559
• Device Sequence Number: 3977444
• Product Code: FZX
• UDI-Device Identifier: 10886982190697
• UDI-Public: (01)10886982190697
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Type of Report: Initial
• Report Date (Section B): 01/09/2021

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: 323.050
• Device Catalogue Number: 323.05
• Initial Date Received by Manufacturer: 01/09/2021
• Initial Report FDA Received Date: 01/29/2021
• Patient Sequence Number: 1