MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.8 VARIABLE ANG LCKNG DRILL GUIDE/CONE; GUIDE, SURGICAL, INSTRUMENT

Model Number	03.110.023
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that, while inspecting the instruments after going through the decontamination process there were 2 instruments that were damaged.This item was a small screwdriver and the wooden handle is cracked.As the wood swells with water and heat the crack is more profound.The second item was a cone and the tip of the cone was bend.However, when the item was set aside a staff member at the hospital disposed of it in the red sharps container and was unable to retrieved due to safety concerns.This report is for (1) 1.8mm variable angle locking drill guide/cone.This is report 1 of 1 for complaint (b)(4).

• Brand Name: 1.8 VARIABLE ANG LCKNG DRILL GUIDE/CONE
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12533441
• Report Number: 2939274-2021-05770
• Device Sequence Number: 1271343
• Product Code: FZX
• UDI-Device Identifier: 10886982071941
• UDI-Public: (01)10886982071941
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/28/2021

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: 03.110.023
• Device Catalogue Number: 03.110.023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/28/2021
• Initial Report FDA Received Date: 09/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1.8 VARIABLE ANG LCKNG DRILL GUIDE/CONE