MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC LCKNG BOLT MEASURING DEVICE F/TFN GAUGE, DEPTH

Model Number 357.402

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

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. If additional information is made available, the investigation will be updated as applicable. 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 reverse logistics audit of returned device at millstone the locking bolt measuring device for tfn was found broken. No patient involvement. This report is for (1) lckng bolt measuring device f/tfn. This is report 1 of 1 for complaint (b)(4).

• Brand Name: LCKNG BOLT MEASURING DEVICE F/TFN
• 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 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12804188
• Report Number: 2939274-2021-06661
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10886982196255
• UDI-Public: (01)10886982196255
• 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: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 357.402
• Device Catalogue Number: 357.402
• Device Lot Number: 6415232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2010
• Is the Device Single Use?: No
• Type of Device Usage: Unkown
• Patient Sex: No Answer Provided
• Patient Weight: KG