MAUDE Adverse Event Report: SYNTHES GMBH 2.4MM/1.8MM DOUBLE DRILL SLEEVE; GUIDE, SURGICAL, INSTRUMENT

Model Number	312.18
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
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 available for evaluation: 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
Device report from synthes reports an event in canada as follows: it was reported that on (b)(6) 2022, the staff have indicated that a few instruments require replacing.The 2.4mm drill bit has some burrs/imperfections and is no longer usable.The 2.4/1.8mm double drill sleeve ¿teeth¿ on the one end are chipped and no longer in working condition.The countersink also has some burrs on the top and requires replacement.The mini quick coupling handle no longer accepts a quick coupling attachment and is therefore also not in working condition.This did not occur intra operatively, so there were no patient issues or surgical delays.This report involves one2.4mm/1.8mm double drill sleeve.This is report 1 of 2 for (b)(4).

• Brand Name: 2.4MM/1.8MM DOUBLE DRILL SLEEVE
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16102778
• Report Number: 8030965-2023-00194
• Device Sequence Number: 11555192
• Product Code: FZX
• UDI-Device Identifier: 10887587036540
• UDI-Public: 10887587036540
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/05/2023

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: 312.18
• Device Catalogue Number: 312.18
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/09/2022
• Initial Report FDA Received Date: 01/05/2023
• 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: 2.4MM DRILL BIT/QC/100MM.; COUNTERSINK FOR 2.0MM/2.4MM SCREWS.; HANDLE WITH MINI QUICK COUPLING.
• Patient Sex: Unknown