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

Catalog Number 319.006

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Unknown when device broke.Device is an instrument and is not implanted/explanted.Part: 319.006; synthes lot: 9848895; supplier lot: na; release to warehouse date: july 14, 2015; manufactured by synthes (b)(4).The raw material was confirmed to be correct per the specification with no (relevant) non-conformance noted.No nonconformance 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.Customer quality investigation: investigation flow: broken.Visual inspection: visual inspection performed at customer quality (cq) observed broken needle on the returned depth gauge.The broken needle portion was not returned.No new issues were identified on the returned portions of the device.The received condition of the device agrees with the reported condition and this complaint is confirmed.Document/specification review: below design drawing from date of manufacture to current was reviewed during this investigation and no issues were identified.Depth gauge top level drawing.Needle drawing.Dimensional inspection on the relevant portions were not performed as the broken portions were not returned.The device history record reviewed showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Material review performed, showed no issues with material that would have contributed to complaint condition.Conclusion: no root cause could be determined with the available information.However, it is possible that any unintended forces encountered by the device which is consistent with repeated usage for over 3 years could have contributed to complaint condition.This complaint is confirmed, however, no unidentified product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation.Therefore, 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 during routing set inspection in the sterile processing department on an unknown date, one (1) depth gauge was found to have snapped off at the threads.There was no patient or procedure involvement.This report is for a depth gauge for 2.0mm and 2.4mm screws.This is report 1 of 1 for (b)(4).

• 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
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7863997
• MDR Text Key: 119815645
• Report Number: 2939274-2018-53707
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10886982189943
• UDI-Public: (01)10886982189943
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 319.006
• Device Lot Number: 9848895
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1