MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM VA DRILL GUIDE

Model Number	03.133.003
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).(b)(6).Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.The investigation could not be completed, no product was received; 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.
Event or Problem Description
It was reported that on (b)(6) 2021, the patient underwent for a surgery.During the surgery, the guidewire (zimmer) that was inside the universal chuck, would not open.It appears 'frozen' and will not unlock.The 3.5mm va drill guide broke after the surgeon was trying to engage the cone side into the locking attachment washer (law) plate.No fragments were generated.There was no surgical delay.The procedure successfully completed.No patient consequence.Concomitant device reported: rfna / 11 / 420 5 deg bend / sterile (part#: 04.233.142s, lot#: unknown, quantity: 1).Lckng attach washer rfna / 5 deg/ rt/ s (part#: 02.233.100s, lot#: unknown, quantity: 1).Universal chuck (part#: 03.043.001, lot#: unknown, quantity: 1).This complaint involves one (1) device.This report is for (1) 3.5mm va drill guide this is report 1 of 11 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.The complaint device was not received for investigation.The images were reviewed and the complaint condition is confirmed.The va drill guide cone appears to have broken off of the body of the drill guide in the photos provided.A definitive assignable root cause could not be determined based on the provided information.As the device was not returned, an as-received condition could not be assessed and a dimensional inspection and document/specification review were not completed.During the investigation, no product design issues or discrepancies were observed (based on the image) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot : product code #: 03.133.003 , synthes lot #: h889472, released to warehouse: 04jun2020, 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.
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: d9 h3, h6: a product investigation was completed: the angle cone had broken off from the rest of the drill guide and the broken piece was returned along with the device.The drill guide appeared to have unknown foreign substance blocking the opening.No other issues were identified.Based on the date of manufacture, the current and manufactured version of the drawings were reviewed.Complaint relevant dimension could not be measured due to the design of the device.Complaint can be confirmed based on the available information.The drill guide was broken and had some foreign substance on it.A definitive root cause was not determined during investigation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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.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: 3.5MM VA DRILL GUIDE
• Common Device Name: GUIDE
• 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: 12897093
• Report Number: 2939274-2021-06861
• Device Sequence Number: 4802377
• Product Code: FZX
• UDI-Device Identifier: 10886982269935
• UDI-Public: (01)10886982269935
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,Followup
• Report Date (Section B): 11/02/2021

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: 03.133.003
• Device Catalogue Number: 03.133.003
• Device Lot Number: H889472
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/02/2021
• Supplement Date Received by Manufacturer: 12/01/2021; 01/18/2022
• Initial Report FDA Received Date: 11/30/2021
• Supplement Report FDA Received Date: 12/27/2021; 02/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LCKNG ATTACH WASHER RFNA / 5 DEG/ RT/ S; RFNA / 11 / 420 5 DEG BEND / STERILE; UNIVERSAL CHUCK; UNK - GUIDES/SLEEVES/AIMING: GUIDE
• Patient Age: 47 YR
• Patient Sex: Male