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

Model Number	319.007
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Part #: 319.007.Synthes lot number: 4451277.Manufacturing site: synthes brandywine.Release to warehouse date: july 26, 2002.The raw material was confirmed to be correct per the specification with no (relevant) non-conformance noted.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.Lot number: 4451277) was received at us customer quality (cq).Visual inspection of the complaint device showed the body component was having difficulties sliding on the slider component.There was no evidence of breakage.Functional test: a functional assessment was performed with the complaint device.The body component grates and sticks when sliding on the slider.The condition can be replicated.Dimensional inspection: drawing.Specified dimensions: slider height = 5.8 +0/-0.05mm.Slider width = 8 -0.02/-0.07mm.Measured dimensions: slider height = 5.77mm, conforming.Slider width = 7.94mm, conforming.Device used ¿ caliper ca802.Document/specification review: current and manufactured were reviewed.Current and manufactured were also reviewed.No design issues or discrepancies were identified.Complaint confirmed? no.Investigation conclusion: this complaint is not confirmed as there is no evidence of breakage.However, the body sticks and grates when sliding on the slider.No root cause could definitively be determined for the reported complaint condition.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.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 march 24, 2020, the depth gauge was discovered broken during reverse logistics audit of returned device at millstone.There was no patient involvement and no additional information is available.This report involves one (1) depth gauge for 2.0mm and 2.4mm screws, long.This is report 1 of 1 for (b)(4).

• Brand Name: DEPTH GAUGE FOR 2.0MM AND 2.4MM 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: 9971913
• Report Number: 2939274-2020-01904
• Device Sequence Number: 2546175
• 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
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/24/2020

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: 319.007
• Device Catalogue Number: 319.007
• Device Lot Number: 4451277
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/24/2020
• Initial Report FDA Received Date: 04/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1