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 Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Part #: 319.006.Synthes lot #: 6219737.Supplier lot #: n/a.Release to warehouse date: 10 sep 2009.Manufactured by: (b)(4).No ncr's generated during production.Visual inspection: the depth gauge for 2.0mm and 2.4mm screws (p/n 319.006, lot number: 6219737) was received at us customer quality (cq).Visual inspection of the complaint device showed the needle component of the device was slightly bent.Also, the device was received assembled with an unknown spring and shaft.Functional test: a functional assessment was performed as the device was received assembled with unknown spring and shaft due to which the device was not functioning as intended.The differences in the components indicate the customer had potentially disassembled the device for cleaning and sterilization and mixed up the component with other device components when reassembling them.Can the complaint be replicated with the returned device(s)? yes.Dimensional inspection: measured dimensions: needle diameter = conforming documentation/ specification review: the following drawing(s) was reviewed: depth gauge for 2.0/ 2.4mm screws, needle, body, no design issues or discrepancies were found during this investigation.Complaint confirmed? yes.Investigation conclusion: the overall complaint was confirmed as the device was received assembled with unknown spring and shaft due to which the device was not functioning as intended.No definitive root cause could be determined based on the provided information.The potential cause for the functional issue could be due to the unintended mixed up during cleaning and sterilization process.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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 during a routine incoming inspection of the loaner set it was observed that the depth gauge for 2.0mm and 2.4 cortex screws, measures up to 50mm was non-functioning.There was no patient involvement.This report is for one (1) 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): BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12520484
• MDR Text Key: 272952607
• Report Number: 2939274-2021-05719
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10886982189943
• UDI-Public: 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/26/2021

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: 6219737
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/26/2021
• Initial Date FDA Received: 09/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1