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).

• 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
• Manufacturer (Section G): BRANDYWINE; 1303 goshen parkway; west chester PA
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA
• MDR Report Key: 11252025
• MDR Text Key: 231238407
• Report Number: 2939274-2021-00556
• Device Sequence Number: 1
• Product Code: HTJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 01/09/2021

1 Device was Involved in the Event

0 Patients were 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

• 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
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/11/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2006
• Is the Device Single Use?: No

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Unkown