MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPTH GAUGE FOR 2.0 AND 2.4 SCREWS, LONG; GAUGE, DEPTH

Model Number	319.007
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A product investigation was conducted.Visual inspection: the depth gauge for 2.0mm and 2.4mm screws, long (p/n: 319.007, lot number: 4911460) was received at us cq.Visual inspection of the complaint device showed the distal tip of the needle was bent, and the body had issues assembling to the slider.Functional test: a functional assessment was performed on the complaint device.The body had issues sliding over the ball and spring attached to the slider.With extra force, the body was able to assemble.The condition could be replicated.Dimensional inspection: a dimensional inspection was not performed since it was not applicable to the complaint condition and 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 distal tip is bent and the ball and spring were stuck, preventing the body from easily assembling onto the slider.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.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 # 319.007.Synthes lot # 4911460.Supplier lot # na.Release to warehouse date: 23 dec 2004.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 the depth gauge for 2.0mm and 2.4mm screws does not function during reverse logistics audit of returned device.There was no patient involvement and no additional information is available.During manufacturer's investigation of the returned device it was identified that the distal tip of the needle was bent, and the body had issues assembling to the slider.This device condition was re-evaluated and determined to be reportable on march 15, 2021.This report is for one (1) depth gauge for 2.0 and 2.4 screws, long.This is report 1 of 1 for (b)(4).

• Brand Name: DEPTH GAUGE FOR 2.0 AND 2.4 SCREWS, LONG
• 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: 11590116
• Report Number: 2939274-2021-01596
• Device Sequence Number: 14498817
• Product Code: HTJ
• UDI-Device Identifier: 10887587039008
• UDI-Public: (01)10887587039008
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/05/2021

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: 319.007
• Device Catalogue Number: 319.007
• Device Lot Number: 4911460
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/15/2021
• Initial Report FDA Received Date: 03/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1