MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPTH GAUGE FOR 2.7MM & SMALL SCREWS; GAUGE, DEPTH

Model Number 319.01

Device Problems Device-Device Incompatibility (2919); Material Deformation (2976)

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

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Initial reporter is synthes sales representative.510k: premarket submission number not available/not released.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.Device was used for treatment, not diagnosis.If additional information is made available, the investigation will be updated as applicable.

Event Description

It was reported that on an unknown date, while inspecting the instruments after going through the decontamination process, it was discovered that some instruments were damaged.The star drive screwdriver shaft is bent and wobbles in the screwdriver handle, wire guide sleeve won't fully insert into the blade guide, blade/screw guide sleeve will not let the blade inserter engage the rifling properly, tube part of depth gauge for screws is bent and will not let the screw down piece engage the threads, the insertion guide was bent and the sleeves were unable to be inserted full.However, it was set aside and inadvertently placed in the sharps container by the staff and was unable to be retrieved.There was no patient involvement with any of these items.This complaint involves five (5) devices.Concomitant products: depth gauge for screws ø 2.7 to 4.0 mm, measuring range up to 60 mm, 3.2mm wire guide sleeve.Blade/screw guide sleeve.Depth gauge for screws ø 2.7 to 4.0 mm, insertion guide.This report is for one (1) depth gauge for 2.7mm & small screws.This report is 4 of 5 for (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.H3, h4, h6: part number:319.01, synthes lot number: 5247448, supplier lot number: n/a, release to warehouse date: 31may2006, expiration date: n/a, manufactured by synthes brandywine.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.Visual inspection: the guide sleeve component of depth gauge for 2.7mm & small screws (product code:319.01 & lot no: 5247448) was received at us customer quality (cq).The visual inspection of the received device showed that the guide sleeve distal end was deformed.The slider assembly, knurled cap, and headpiece components were missing.Device failure/defect identified? yes.Dimensional inspection: the dimensional inspection cannot be performed due to the post-manufactured damage and the definitive finding of missing components.Document/specification review? the following drawings reflecting the current and manufactured revisions were reviewed: depth gauge for 2.7mm to 4.0 mm screws.Service and repair evaluation: the customer reported the tube part of the depth gauge for screws is bent and will not let the screw down piece engage the threads.The repair technician reported there were no parts sent with the device.Missing parts 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.Complaint confirmed? yes.Conclusion: the overall complaint was confirmed for the received device as the guide sleeve component in the device was deformed and the slider assembly, knurled cap, and headpiece components were missing.The alleged device interaction issue may also be caused due to the deformed guide sleeve component.No definitive root cause could be determined based on the provided information.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.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 2.7MM & 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: 11252025
• MDR Text Key: 231238407
• Report Number: 2939274-2021-00556
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10886982189950
• UDI-Public: (01)10886982189950
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 319.01
• Device Catalogue Number: 319.01
• Device Lot Number: 5247448
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2021
• Date Manufacturer Received: 02/11/2021
• Patient Sequence Number: 1
• Treatment: 3.2MM WIRE GUIDE SLEEVE; BLADE/SCREW GUIDE SLEEVE; DEPTH GAUGE FOR SCREWS Ø 2.7 TO 4.0 MM,; INSERTION GUIDE; STARDRIVE SCWDRVR SFT SD6/SLF-RETAINING/2.0MM