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 Problems Break (1069); Mechanical Jam (2983); Physical Resistance/Sticking (4012)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Reporter: synthes employee.Part 319.006, lot a4jd496: release to warehouse date: december 19, 1998.Manufactured by synthes (b)(4).No non-conformance reports (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.A product investigation was completed: the depth gauge was received with the needle component broken from the slider.The transverse fracture of the needle is located at the interface between the needle and slider.No other issues were identified.Functional testing was performed by sliding the body along the slider.The body was able to slide along the slider without any issues.The reported complaint condition of jammed/seized could not be replicated as the body was able to slide along the slider without any issues.The device failure/defect of broken needle was identified during the investigation and is not related to the reported complaint condition.Dimensional inspection showed the relevant dimensions were conforming.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.The complaint condition of jammed/seized is not confirmed as the body was able to slide along the slider.A new defect/failure was identified during the investigation.The needle component was broken from the slider.No definitive root cause could be determined for the broken needle.It is possible that the broken condition was due to excessive/unintended forces during device use.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 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 an unknown date, the two depth gauge do not slide like they should even after lubrication.The devices came from the sterile processing department (spd).There was no procedure and patient involvement.This is report 1 of 2 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.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: 8939125
• MDR Text Key: 155809803
• Report Number: 2939274-2019-60147
• 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,health
• Type of Report: Initial,Followup
• Report Date: 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2019
• 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: A4JD496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2019
• Date Manufacturer Received: 08/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1