MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPTH GAUGE FOR MINI SCREWS XL; GAUGE, DEPTH

Model Number	319.06
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is a j&j employee.A product investigation was conducted.Visual inspection: the depth gauge for mini screws xl was received at us cq.Upon visual inspection, the needle subcomponent is cracked at the base and the needle is bent dimensional inspection: a dimensional inspection was performed on the returned device.The outer diameter of the needle component was measured and is within the specification per relevant drawing.Document/specification review: the following drawings were reviewed: depth gauge for 2.0/2.4 mm screws needle investigation conclusion: the complaint is confirmed as the device was received with the needle broken at the base, with part of it lodged in the slider component.The rest of it is slightly deformed with an unintended curvature and slight deformation at the point of breakage.No definitive root-cause can be determined based on the provided information.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.A device history record (dhr) review was conducted: part # 319.006, synthes lot # a4jh095, supplier lot # na, release to warehouse date: 01 feb 1999, manufactured by synthes (b)(4).No ncr's 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.
Event or Problem Description
It was reported that on an unknown date, during a routine incoming inspection of a loaner set, it was observed that the depth gauge for mini screws was broken.There was no patient or hospital involvement.This report is for 1 depth gauge for mini screws xl.This is report 1 of 1 for complaint (b)(4).

• Brand Name: DEPTH GAUGE FOR MINI SCREWS XL
• Common Device Name: GAUGE, DEPTH
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10943177
• Report Number: 2939274-2020-05435
• Device Sequence Number: 14245523
• Product Code: HTJ
• UDI-Device Identifier: 10886982189981
• UDI-Public: (01)10886982189981
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/09/2020

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: 319.06
• Device Catalogue Number: 319.06
• Device Lot Number: A4JH095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/09/2020
• Initial Report FDA Received Date: 12/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1