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

Model Number 319.006

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/05/2019

Event Type  malfunction  

Manufacturer Narrative

Occupation: reporter is a synthes employee.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 Description

It was reported that on (b)(6) 2019 a depth gauge metal hook broke off during an unknown procedure while the surgeon was pulling on the handle to hook the depth gauge on bone.The procedure was completed using a peel packed depth gauge of the same type and the broken piece of the depth gauge was easily removed with a heavy needle driver.It was unknown if there was a surgical delay and there was no patient consequence reported.This report is for one (1) depth gauge for 2.0 mm and 2.4 mm screws.This is report 1 of 1 for (b)(4).

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 investigation summary: visual inspection: the depth gauge for 2.0mm and 2.4mm screws (p/n 319.006 lot 5725708) was received with the needle component broken off from the slider.The transverse fracture was located at the interface between the needle and slider.The broken off needle component was not returned.The protection sleeve component was not returned and is missing.Dimensional inspection: dimensional inspection could not be conducted as the broken off needle component was not returned.The missing sleeve was visually confirmed.Document/specification review: the respective 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 (p/n 319.006 lot 5725708) as the needle component was broken off from the slider and was not returned.The protection sleeve component was not returned and is missing.No definitive root cause could be determined.It is possible that consistent use and reprocessing over the part¿s lifetime contributed to the breakage of the needle.It is possible that the protection sleeve was misplaced during surgery/reprocessing.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.Device history lot: part # 319.006.Synthes lot # 5725708.Supplier lot # na release to warehouse date: 29 feb 2008 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
• Type of Device: GAUGE,DEPTH
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9130359
• MDR Text Key: 160538073
• Report Number: 2939274-2019-60979
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10886982189943
• UDI-Public: (01)10886982189943
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/05/2019

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
• Device Operator: Health Professional
• Device Model Number: 319.006
• Device Catalogue Number: 319.006
• Device Lot Number: 5725708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2019
• Initial Date Manufacturer Received: 09/05/2019
• Initial Date FDA Received: 09/27/2019
• Supplement Dates Manufacturer Received: 09/30/2019
• Supplement Dates FDA Received: 10/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1