MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPTH GAUGE FOR SMALL SCREWS; GAUGE, DEPTH

Model Number 319.09

Device Problem Material Deformation (2976)

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

Event Type  malfunction  

Manufacturer Narrative

Reporter is a j&j employee.The subject device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing 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.

Event Description

It was reported that on an unknown date, during a routine incoming inspection of a loaner set, it was observed that the depth gauge for small screws was bent.There was no known patient or hospital involvement.This report is for one (1) depth gauge for small screws.This is report 1 of 1 for complaint (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H3, h6: product code: 319.090.Lot number: l977022.Manufacturing site: bettlach.Release to warehouse date: 18.Sep.2018.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Lot l906868 belongs to the component part 319.090.500 which belongs to the assembly group 319.090 lot l977022.Part: 319.090.500.Lot: l906868.Manufacturing site: bettlach.Release to warehouse date: 30 july 2018.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the depth gauge for small screws (p/n: 319.09, lot #: l906868) was returned and received at us customer quality (cq).Upon visual inspection, it was observed that the lot number on the outer sleeve is l977022 and the lot number on the slider assembly was l906868.The differences in the lot numbers between the components indicates the customer had potentially disassembled the devices for cleaning and sterilization and mixed up the components with other device components when reassembling them.The measuring hook component was observed to be bent.No other issues were observed with the returned device.Device failure/defect identified? yes.Service and repair evaluation: the customer reported that the depth gauge for small screws was bent.The repair technician reported the device tip is bent.Bent is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is unknown.The item will be forwarded to customer quality.The evaluation was confirmed.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Furthermore, the complaint relevant dimensions cannot be checked for dimensional accuracy, because of the design of the device.Document/specification review based on the date of manufacture, the current and manufactured revision of drawings were reviewed.-measuring range up to 110 m.Complaint confirmed? yes, the device received was bent.Hence confirming the allegation.Investigation conclusion: the complaint condition was confirmed for the depth gauge for small screws (p/n: 319.09, lot #: l906868).The differences in the lot numbers between the components indicates the customer had potentially disassembled the devices for cleaning and sterilization and mixed up the components with other device components when reassembling them.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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.

• Brand Name: DEPTH GAUGE FOR SMALL 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: 11780536
• MDR Text Key: 249745918
• Report Number: 2939274-2021-02231
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10886982189998
• UDI-Public: (01)10886982189998
• 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
• Type of Report: Initial,Followup
• Report Date: 04/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 319.09
• Device Catalogue Number: 319.09
• Device Lot Number: L977022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2021
• Date Manufacturer Received: 05/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1