MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS-70MM; GAUGE, DEPTH

Model Number SD319.002

Device Problem Use of Device Problem (1670)

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

Event Type  malfunction  

Manufacturer Narrative

If the information is unknown, not available or does not apply, the section/field of the form is left blank.A product investigation was conducted.Visual inspection: the complaint device depth gauge for 2.0 and 2.4 screws-70 (product code: (b)(4), lot number: 7819728) was returned to cq west chester for investigation.The device was missing the parallel pin present in the body.The depth gauge needle was bent and the handle had been severely scratched & discolored.Document/specification review: based on the date of manufacture, the current and manufactured version of drawings were reviewed.Dimensional inspection: diameter of needle was measured and found to be conforming as per relevant drawing.Investigation conclusion: the depth gauge parallel pin in on the body was missing and the needle had bent.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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.A device history record (dhr) review was conducted: part number:sd319.002, synthes lot number: 7819728, supplier lot number: n/a.Release to warehouse date: 25feb2015.Expiration date: n/a.Manufactured by synthes (b)(6).No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.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, the 2.0/2.4mm depth gauge was found by sterile processing department to be missing the antirotation pin from the outer sleeve of the depth gauge.There was no patient involvement.This report is for one (1) depth gauge for 2.0mm and 2.4mm screws-70mm this is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

A product investigation was conducted.Visual inspection: the complaint device depth gauge for 2.0 and 2.4 screws-70 (product code: sd319.002, lot number: 7819728) was returned to cq west chester for investigation.The device was missing the parallel pin present in the body.The depth gauge needle was bent and the handle had been severely scratched & discolored.Document/specification review: based on the date of manufacture, the current and manufactured version of drawings were reviewed.Dimensional inspection: diameter of needle was measured and found to be conforming as per relevant drawing.Investigation conclusion: the depth gauge parallel pin in on the body was missing and the needle had bent.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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.A device history record (dhr) review was conducted: part number:sd319.002, synthes lot number: 7819728, supplier lot number: n/a.Release to warehouse date: 25feb2015.Expiration date: n/a.Manufactured by synthes (b)(6).No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.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, the 2.0/2.4mm depth gauge was found by sterile processing department to be missing the antirotation pin from the outer sleeve of the depth gauge.There was no patient involvement.This report is for one (1) depth gauge for 2.0mm and 2.4mm screws-70mm this is report 1 of 1 for complaint (b)(4).

• Brand Name: DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS-70MM
• 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 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 13417010
• MDR Text Key: 286119100
• Report Number: 2939274-2022-00319
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10886982004925
• UDI-Public: (01)10886982004925
• 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

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: SD319.002
• Device Catalogue Number: SD319.002
• Device Lot Number: 7819728
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2022
• Initial Date FDA Received: 02/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2015
• 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