MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.5/1.1 DBL DRILL SLV 1.5 CORTEX SCR/RED; GUIDE, SURGICAL, INSTRUMENT

Model Number	03.130.225
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.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, during a surgical procedure was performed for unknown reason.The drill guide broke, cutter doesn¿t work, and t4 shaft is bent at the head.It is unknown the procedure was completed successfully but there was a surgical delay and no patient consequence.Concomitant device reported: 1.5mm val straight plate 12 holes (part# 02.130.251; lot# unknown; quantity: 1).This report is for one (1) 1.5/1.1mm double drill sleeve for 1.5mm cortex screws/red.This is report 1 of 2 for complaint (b)(4).

• Brand Name: 1.5/1.1 DBL DRILL SLV 1.5 CORTEX SCR/RED
• 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: 11856567
• Report Number: 2939274-2021-02470
• Device Sequence Number: 19878962
• Product Code: FZX
• UDI-Device Identifier: 10886982075406
• UDI-Public: (01)10886982075406
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 04/22/2021

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: 03.130.225
• Device Catalogue Number: 03.130.225
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/22/2021
• Initial Report FDA Received Date: 05/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1