MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC PERCUTANEOUS DEPTH GAUGE FOR 2.7MM SCREWS; FORCEPS

Model Number	03.118.007
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: reporter is a j&j employee.A product investigation was conducted.Visual inspection: the percutaneous depth gauge for 2.7 mm screws (part #: 03.118.007, lot #: l348287) was returned and received at us cq.Upon visual inspection, it was observed that the distal tip of the hook component was bent.No other issues were identified with the returned device.Dimensional inspection: the dimensional inspection was performed on the returned device.The outer diameter of the hook was measured and is within the specification per relevant drawing.Document/specification review: based on the date of manufacture the following drawings, reflecting the current and manufactured revision were reviewed: investigation conclusion: the complaint condition was confirmed for the precutaneous depth gauge for 2.7 mm screws (part #: 03.118.007, lot #: l348287).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.A device history record (dhr) review was conducted: part: 03.118.007, lot: l348287, manufacturing site: (b)(4), release to warehouse date: 07.Apr.2017, 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.
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 percutaneous depth gauge for 2.7 mm screws was bent.There was no patient involvement.This report is for one (1) percutaneous depth gauge for 2.7 mm screws.This is report 1 of 1 for (b)(4).

• Brand Name: PERCUTANEOUS DEPTH GAUGE FOR 2.7MM SCREWS
• Common Device Name: FORCEPS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10551165
• Report Number: 2939274-2020-04192
• Device Sequence Number: 11521337
• Product Code: HTD
• UDI-Device Identifier: 10886982073365
• UDI-Public: (01)10886982073365
• 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
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/28/2020

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: 03.118.007
• Device Catalogue Number: 03.118.007
• Device Lot Number: L348287
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/25/2020
• Initial Report FDA Received Date: 09/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1