MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM/6.5MM STEPPED DRILL BIT LARGE QC/485MM; BIT, DRILL

Model Number	03.010.078
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure on an unknown date, it was noted that the drill stop failed on the drill bit for recon screws and the drill bit advanced into and past the pelvis.The bladder did not appear to be perforated at the time of surgery, but additional tests (ct scan) were ordered to confirm.A second drill bit was provided, and the drill stop failed again.Procedure was successfully completed with no surgical delay.No patient consequences were noted.This report is for a 4.5mm/6.5mm stepped drill bit.This is report 2 of 2 for (b)(4).
Additional Manufacturer Narrative
Date of event is an unknown date in 2021.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing 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.
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: h3, h6: a product investigation was conducted.Visual inspection: the complaint device 4.5/6.5 stepped drill bit large qc/485 (product code: 03.010.078, lot number: pe04807) was returned to cq west chester for investigation along with stepped drill bits.The drill stop will be investigated under a different pi.The drill bit had scratches and circular marks that are identified to be due to use and did not contribute to the complaint condition.Functional test: the drill stop was attached to the drill bit.The fit of the stop over the drill bit was evaluated by applying pressure and the drill bit did not move after many tries.Hence, the drill bit and drill stop had no issues.The complaint condition of misalignment cannot be confirmed as no other mating device was returned to evaluate the full alignment.The complaint cannot be replicated as the drill bit functioned as intended during evaluation.Dimensional inspection: no issues warranting a dimensional inspection were identified on the device.Document/specification review: based on the date of manufacture, the current and manufactured to version of drawing were reviewed.Conclusion: the drill bit had some scratches which does not contribute to the complaint condition and the device worked as intended during evaluation.Hence, the complaint could not be confirmed.A definitive assignable root cause could not be determined from the available information.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.H3, h4, h6: a device history record (dhr) review was conducted: part #: 03.010.078.Synthes lot #: pe04807.Supplier lot #: pe04807 released to warehouse: 23apr2021.Supplier: (b)(4).No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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.

• Brand Name: 4.5MM/6.5MM STEPPED DRILL BIT LARGE QC/485MM
• Common Device Name: BIT, DRILL
• 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: 12983176
• Report Number: 2939274-2021-07059
• Device Sequence Number: 5014356
• Product Code: HTW
• UDI-Device Identifier: 10886982067487
• UDI-Public: (01)10886982067487
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2021

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: 03.010.078
• Device Catalogue Number: 03.010.078
• Device Lot Number: PE04807
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/14/2021
• Supplement Date Received by Manufacturer: 12/23/2021
• Initial Report FDA Received Date: 12/13/2021
• Supplement Report FDA Received Date: 01/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2021
• 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: 4.5/6.5 STEPPED DRILL BIT LARGE QC/485; DRILL STOP FOR 4.5/6.5 STEPPED DRILL BIT; DRILL STOP FOR 4.5/6.5 STEPPED DRILL BIT
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 68 KG