MAUDE Adverse Event Report: SYNTHES GMBH DRILL BIT/ CALIBRATED/ 4.2 EXTRA-LONG; TEMPLATE

Model Number	03.045.022
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2023, when drilling for screw placement in the proximal end of the ans tibia nail, the most distal screw (in the proximal section) the drill bit hit the nail and didn¿t pass through the nail.In addition, the tna aiming arm does not appear to line up with the nail properly.When drilling the proximal static medial to lateral screw, the 4.2 drill bit was hitting the nail instead of the hole in the nail.There was a mild delay in surgery.The surgeon decided to not use the hole that the drill bit was missing and moved on to another hole in the nail.The procedure was completed successfully, no fragments were generated.It was unknown if there was any patient outcome/consequences.This complaint involves four (4) devices.This report is for one (1) drill bit/ calibrated/ 4.2 extra-long this is report 2 of 4 for complaint (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: a1: patient id also reported as (b)(6).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.B5.
Event or Problem Description
This is report 2 of 7 for (b)(4).

• Brand Name: DRILL BIT/ CALIBRATED/ 4.2 EXTRA-LONG
• Common Device Name: TEMPLATE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16506502
• Report Number: 8030965-2023-02904
• Device Sequence Number: 15027120
• Product Code: HWT
• UDI-Device Identifier: 10886982292650
• UDI-Public: (01)10886982292650
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup

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: 03.045.022
• Device Catalogue Number: 03.045.022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/20/2023
• Supplement Date Received by Manufacturer: 04/20/2023
• Initial Report FDA Received Date: 03/08/2023
• Supplement Report FDA Received Date: 04/20/2023
• 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: 4.2 3-FLTD DRILL BIT QC/330/100 CALIB; AIMING ARM/ RADIOLUCENT; COMPRESSION SCREW/ SHORT; CONNECTING SCREW/ CANNULATED LONG; DRILL SLEEVE / 4.2MM; INSERTION HANDLE/ RADIOLUCENT LONG; PROTECTION SLEEVE/ 11/8; UNK - NAILS
• Patient Age: 29 YR
• Patient Sex: Male