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 Consequences Or Impact To Patient (2199)

Event Date 05/01/2018

Event Type  malfunction  

Manufacturer Narrative

No patient involvement reported.Exact date is unknown.Reporter is synthes sales representative.Device history records review was completed for part# 319.006, lot# 4890857.Manufacturing location: (b)(4), release to warehouse date: nov 15, 2004.No non conformance reports were generated during production.The raw material was confirmed to be correct per the specification with no relevant non-conformance noted.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Product investigation was completed.Visual inspection performed at customer quality (cq) observed broken needle on the returned depth gauge.The needle was observed broken at its threaded connection end to the body of the depth gauge.No new issues were observed on the returned portions (needle, body and slider) of the device.The given complaint condition agrees with the returned device condition and therefore the complaint was confirmed.Relevant design drawings, reflecting the current and manufactured revision, were reviewed and no design issues were identified.Dimensional analysis was not able to be performed at the exact location of breakage as the exact thread measurement was not able to be obtained due to the breakage.However, the needle dimension measured proximal to the thread portion measured the diameter as 1.23 mm (ca-814) that falls within the specification of 1.2 mm to 1.25 mm.No definitive root cause was able to be determined with the available information.However, any possible unintended excessive force on the device during usage/during handling could have contributed to this broken tip condition.The overall complaint condition was confirmed; however, no product design issues or manufacturing discrepancies were identified during this investigation.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 (b)(6) 2018, there was an unknown malfunction of the devices discovered in the sterile processing department involving two (2) depth gauges, one (1) hexagonal screwdriver, and one (1) stardrive screwdriver shaft.There was no patient involvement.Visual inspection performed at customer quality (cq) observed broken needle on the returned depth gauge.This report is for one (1) depth gauge.This is report 1 of 4 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): BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7948581
• MDR Text Key: 123404467
• Report Number: 2939274-2018-54267
• 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: 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2018
• 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: 4890857
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2004
• 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