MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS-70MM; GAUGE, DEPTH

Model Number	SD319.002
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 (b)(6) 2019 by the senior processing department manager about a depth gauge that had a broken shaft.There is no patient involvement.This complaint involves one (1) device.This report is for one (1) depth gauge for 2.0 mm and 2.4 mm screws-70 mm this is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: h3, h6: a product investigation was conducted.Visual inspection: the depth gauge for 2.0mm and 2.4mm screws-70mm (p/n sd319.002 lot 9944464) was received with the needle component broken off, with the transverse fracture located at the interface between the needle and slider.The broken off needle component was not returned.The returned depth gauge was in a heavily used condition, as discoloration was observed along its components.Dimensional inspection: dimensional inspection was not conducted as the broken off needle was not returned.Document/specification review: the relevant drawings, reflecting the manufactured and current revision, were reviewed.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.Conclusion: the complaint condition is confirmed for the depth gauge for 2.0mm and 2.4mm screws-70mm (p/n sd319.002 lot 9944464) as the needle component was broken off.The returned depth gauge was in a heavily used condition, as discoloration was observed along its components, likely due to normal wear and reprocessing.While no definitive root cause could be determined, it is possible that the device encountered unintended forces/dense bone, leading to the needle breakage.During this investigation no product design or manufacturing issues were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.H3, h4, h6: a device history record (dhr) review was conducted: part # sd319.002.Synthes lot # 9944464.Supplier lot # na.Release to warehouse date: 22 mar 2016.Manufactured by synthes brandywine.The raw material was confirmed to be correct per the specification with no (relevant) non-conformance noted.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.

• Brand Name: DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS-70MM
• 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: 9111386
• Report Number: 2939274-2019-60853
• Device Sequence Number: 3070394
• Product Code: HTJ
• UDI-Device Identifier: 10886982004925
• UDI-Public: (01)10886982004925
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2019

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: SD319.002
• Device Catalogue Number: SD319.002
• Device Lot Number: 9944464
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2019
• Initial Date Received by Manufacturer: 08/27/2019
• Supplement Date Received by Manufacturer: 09/26/2019
• Initial Report FDA Received Date: 09/24/2019
• Supplement Report FDA Received Date: 10/16/2019
• Patient Sequence Number: 1