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	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative:.Initial reporter is synthes 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.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 (b)(6) as follows: it was reported that on an unknown date, the surgeon had difficulty inserting the va drill guides into the va holes.The guide was not seating properly.No other information is available.This report is for one (1) 1.8 variable ang lckng drill guide/cone this is report 2 of 5 for (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
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13577158
• Report Number: 2939274-2022-00588
• Device Sequence Number: 4533053
• Product Code: FZX
• UDI-Device Identifier: 10886982071941
• UDI-Public: (01)10886982071941
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2022
• Initial Report FDA Received Date: 02/22/2022
• 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: 1.8 VARIABLE ANG LCKNG DRILL GUIDE/CONE; 1.8 VARIABLE ANG LCKNG DRILL GUIDE/CONE; 2.0 VA LCKNG DRILL GUIDE/VARIABLE; 2.0 VA LCKNG DRILL GUIDE/VARIABLE
• Patient Sex: Unknown