MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.0MM/1.5MM DOUBLE DRILL SLEEVE; GUIDE, SURGICAL, INSTRUMENT

Model Number	312.22
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.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 on (b)(6) 2020 during an unknown procedure the 1.5mm drill bit and the double drill guide broke off during the case.The procedure was successfully completed with the use of another drill bit and drill sleeve.It is unknown if there was a surgical delay.Patient status is unknown.This report is for one (1) 2.0mm/1.5mm double drill sleeve.This is report 2 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.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 foot procedure on (b)(6) 2020, the 1.5mm drill bit broke off in drill sleeve.Concomitant device reported: 1.5mm drill bit/qc/85mm (part # 310.15, lot # unknown, quantity 1).

• Brand Name: 2.0MM/1.5MM DOUBLE DRILL SLEEVE
• 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: 10852475
• Report Number: 2939274-2020-05183
• Device Sequence Number: 2322803
• Product Code: FZX
• UDI-Device Identifier: 10886982187680
• UDI-Public: 10886982187680
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2020

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: 312.22
• Device Catalogue Number: 312.22
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/21/2020
• Supplement Date Received by Manufacturer: 11/23/2020
• Initial Report FDA Received Date: 11/17/2020
• Supplement Report FDA Received Date: 12/10/2020
• 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: 1.5MM DRILL BIT/QC/85MM