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.It is unknown when device broke.Device is an instrument and is not implanted/explanted.Part: 319.006; synthes lot: 6446187; release to warehouse date: august 09, 2010; manufacturing site: (b)(4); no nonconformance reports (ncrs) 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 record(s) showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.Customer quality investigation: the following investigations were performed: broken: device condition: visual inspection performed at customer quality (cq) observed that the returned depth gauge needle was broken.The broken needle was not returned at customer quality.The depth gauge body and slider assembly were returned, and no new issues were identified on the returned parts.Dimensional analysis and document/specification review: drawing review: based on the date of manufacture the following drawings, reflecting the current and manufactured revision, were reviewed.No design issues were identified.Top level drawing for depth gauge assembly.Needle drawing.Dimensional inspection on relevant features were not able to be performed as the broken needle was not returned.Lot number review: a review of the device history records (dhr) showed that there were no issues at the time of manufacturing of this device and its sub components that would contribute to the complaint condition.No ncrs were generated during the production of this device.Also, material review performed during dhr review showed that the raw material was confirmed to be correct per the specification with no (relevant) non-conformance noted.Conclusion: a definitive root cause for the given complaint condition could not be determined from the provided information.However, it is likely that any unintended excessive forces during usage along with consistent usage over 8 years could have contributed to complaint condition.The overall complaint condition is 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 during a routine inspection on (b)(6) 2018, a depth gauge for screws had a broken tip.Additionally, a cable tensioner was tight when it was attempted to run a cable through it, and the cable became stuck.No patient or surgical involvement was reported.Concomitant device: cable (part: unknown, lot: unknown, quantity: 1).This report is for a depth gauge for 2.0mm and 2.4mm screws.This is report 2 of 2 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 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7852097
• MDR Text Key: 119495881
• Report Number: 2939274-2018-53651
• 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: 06/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2018
• 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: 6446187
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2010
• 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