MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPTH GAUGE FOR 1.3MM AND 1.5MM SCREWS; GAUGE,DEPTH

Model Number 319.004

Device Problem Material Deformation (2976)

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

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4) additional narrative: investigation summary investigation flow: damage.Visual inspection: the depth gauge for 1.3mm and 1.5 mm screws (p/n: 319.004, lot #: h694161) was returned and received at us cq.Upon visual inspection, it was observed that the distal tip of the needle component was bent.No other issues were observed with the returned device.The device failure/defect was identified.Document/specification review based on the date of manufacture, the current and manufactured revision of drawings were reviewed.The complaint was confirmed.The device received was bent.Hence confirming the allegation.Investigation conclusion the complaint condition is confirmed for the depth gauge for 1.3mm and 1.5 mm screws (p/n: 319.004, lot #: h694161.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied to the device and the potential cause for missing protection sleeve could be due to device incorrectly assembled during the sterilization process.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 history lot: part # 319.004, synthes lot # h694161, supplier lot # h694161, release to warehouse date: may 15, 2019, supplier: avalign technologies-nemcomed, no ncr's were generated during production.Device history review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, 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, during a routine incoming inspection of the loaner set at fsl ups duluth, ga site, it was observed that the depth gauge for 1.3 mm and 1.5mm screws was bent.There was no known patient or hospital involvement.This complaint involves one (1) device.This report is for (1) depth gauge for 1.3mm and 1.5mm screws.This report is 1 of 1 for (b)(4).

• Brand Name: DEPTH GAUGE FOR 1.3MM AND 1.5MM 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): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11901707
• MDR Text Key: 266905195
• Report Number: 2939274-2021-02662
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10886982189936
• UDI-Public: (01)10886982189936
• 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: 05/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 319.004
• Device Catalogue Number: 319.004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2021
• Date Device Manufactured: 05/15/2019
• 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