MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - NAIL INSERTION HANDLES; MISC ORTHO SURGICAL INSTR

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).This report is for an unk - nail insertion handles/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/ investigation.Reporter is a j&j representative.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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, (3) driving caps were located in sterile processing all broken.Sterile processing said they broke trying to disassemble the stoke cap from the unknown insertion handle.There was no procedure and patient involvement.This complaint involves (4) devices.This report is for (1) unk - nail insertion handles.This report is 2 of 4 for (b)(4).

• Brand Name: UNK - NAIL INSERTION HANDLES
• Type of Device: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13120457
• MDR Text Key: 284696897
• Report Number: 2939274-2021-07307
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: DRIVING CAP/THREADED; DRIVING CAP/THREADED; DRIVING CAP/THREADED