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 Problems Material Deformation (2976); Material Twisted/Bent (2981)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: investigation flow: damage.Visual inspection: the depth gauge for 2.0mm and 2.4mm screws (part# 319.006, lot# h786310, qty# 1) was received at us cq.Upon visual inspection at cq, it is observed that the needle part got deformed at the distal tip.Rest of the surface of the device shows normal wear consistent with the device use which would not contribute to the complaint condition.Thus, the complaint is being confirmed.Device failure/ defect found? yes.Dimensional inspection (calipers: ca122p): dimensional inspection of the received device was performed at cq.The diameter of the needle near to the bent location was intended to be measuring from 1.20mm to 1.25mm and it was measured to be 1.22mm which is within specification.Documentation/ specification review: no design issues or discrepancies were found during this investigation.Complaint confirmed? yes.Investigation conclusion: the complaint is being confirmed for depth gauge for 2.0mm and 2.4mm screws (part# 319.006, lot# h786310) as it is observed that the needle part got deformed at the distal tip.A definitive root cause could not be determined for the reported problem, but there is high possibility that the needle component might have encountered unintended forces.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.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 # 319.006.Synthes lot # h786310.Supplier lot # h786310.Release to warehouse date: dec 20, 2019.Supplier: avalign technologies nemcomed.No ncr's were generated during production.Device history review: 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 during a routine incoming inspection of a loaner set at fsl ups (b)(6) site on an unknown date, the depth gauge for 2.0mm and 2.4mm screws was observed bent.There were no patient and surgical involvement.This complaint involves 2 devices.This report is for (1) depth gauge for 2.0mm and 2.4mm screws.This is report 1 of 2 for (b)(4).

Event Description

This complaint involves one (1) device.

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.H6: a product investigation was conducted: investigation flow: damage.Visual inspection: the depth gauge for 2.0mm and 2.4mm screws (part# 319.006, lot# h786310, qty# 1) was received at us cq.Upon visual inspection at cq, it is observed that the needle part got deformed at the distal tip.Rest of the surface of the device shows normal wear consistent with the device use which would not contribute to the complaint condition.Thus, the complaint is being confirmed.Device failure/ defect was found.Dimensional inspection (calipers: ca122p): dimensional inspection of the received device was performed at cq.Documentation/ specification review: no design issues or discrepancies were found during this investigation.Complaint was confirmed.Investigation conclusion: the complaint is being confirmed for depth gauge for 2.0mm and 2.4mm screws (part# 319.006, lot# h786310) as it is observed that the needle part got deformed at the distal tip.A definitive root cause could not be determined for the reported problem, but there is high possibility that the needle component might have encountered unintended forces.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.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 # 319.006; synthes lot # h786310; supplier lot # h786310; release to warehouse date: dec 20, 2019.Supplier: (b)(4).No ncr's were generated during production.Device history review: 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.

• 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
• MDR Report Key: 10804650
• MDR Text Key: 215285839
• Report Number: 2939274-2020-04999
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10886982189943
• UDI-Public: (01)10886982189943
• 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,health
• Type of Report: Initial,Followup
• Report Date: 10/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• 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: H786310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2020
• Date Manufacturer Received: 11/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1