MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC ADJUSTABLE DRILL GUIDE; MISC ORTHO SURGICAL INSTR

Model Number	03.161.023
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been 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.
Event or Problem Description
It was reported that on (b)(6) 2020, the adjustable drill guide malfunctioned and broke during the procedure.The instrument was removed from sterile field and replaced with new one.There was a ten (10) minutes surgical delay.Procedure was successfully completed.There was no patient consequence.Concomitant devices reported: 3.2mm drill bit qc/245mm (part number 03.161.024, lot u329026, quantity 1).This report involves one (1) adjustable drill guide.This is report 1 of 1 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H3, h6: a product investigation was conducted.Visual inspection: the adjustable drill guide (p/n: 03.161.023, lot number: 4l24678) was received at us cq.Upon visual inspection, the stem assembly is stuck onto the returned mating device (03.161.024) and the weld on the peg subcomponent has broken.Functional test: a functional assessment was performed with the returned devices.The stem assembly could not be removed from the mating device (03.161.024).The condition can be replicated.Dimensional inspection: no dimensional inspection can be performed due to post manufacturing damage.Document/specification review: relevant drawings were reviewed.No design issues or discrepancies were identified.Investigation conclusion: this complaint is confirmed as the stem assembly component is stuck on the mating device and the weld on the peg subcomponent has broken.No definitive root cause could be determined based on the provided information.No new, unique or different patient harms were identified as a result of this evaluation.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.H3, h4, h6: a device history record (dhr) review was conducted: part: 03.161.023-us: lot: 4l24678; manufacturing site: hägendorf; release to warehouse date: 04.July 2019; a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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: ADJUSTABLE DRILL GUIDE
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9917468
• Report Number: 2939274-2020-01677
• Device Sequence Number: 2827172
• Product Code: LXH
• UDI-Device Identifier: 10705034711584
• UDI-Public: (01)10705034711584
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2020

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: 03.161.023
• Device Catalogue Number: 03.161.023
• Device Lot Number: 4L24678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2020
• Initial Date Received by Manufacturer: 03/06/2020
• Supplement Date Received by Manufacturer: 04/03/2020
• Initial Report FDA Received Date: 04/02/2020
• Supplement Report FDA Received Date: 04/23/2020
• 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: 3.2MM DRILL BIT QC/245MM
• Patient Age: 25 YR