MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 16MM CANNULATED HOLLOW DRILL BIT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	03.037.004
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Part 03.037.004, lot 190483-201: manufacturing site: (b)(4).Supplier: (b)(4).Release to warehouse date: march 03, 2020.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified.A product investigation was completed: upon visual inspection, the laser weld to secure the spring component to the centering attachment was broken.The spring component was not returned.No dimensional inspection can be performed due to post-manufacturing damage.Furthermore, the complaint relevant dimensions cannot be checked for dimensional accuracy, because of the design of the device and the spring not returned.The relevant drawings were reviewed; no product design issues or discrepancies were observed during this investigation.The complaint condition was confirmed.There is no indication that a design or manufacturing issue has caused the issue and hence the root cause cannot be determined.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.
Event or Problem Description
It was reported on an unknown date, during sterile processing the cannulated hollow drill bit was missing the retention pin.As a result, the sliding piece will not stay in position.There was no patient involvement.During the investigation by the manufacturer, it was noted that the laser weld to secure the spring component to the centering attachment was broken.This report is for a drill bit.This is report 1 of 1 for (b)(4).

• Brand Name: 16MM CANNULATED HOLLOW DRILL BIT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10970398
• Report Number: 2939274-2020-05502
• Device Sequence Number: 871357
• Product Code: LXH
• UDI-Device Identifier: 10886982070203
• UDI-Public: (01)10886982070203
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/15/2020

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: 03.037.004
• Device Catalogue Number: 03.037.004
• Device Lot Number: 190483-201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2020
• Initial Report FDA Received Date: 12/08/2020
• Patient Sequence Number: 1