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 Break (1069); Material Deformation (2976)

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

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j sales 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 conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, it has been determined that no corrective and 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 on an unknown date, the patient underwent for a surgery.During the procedure, two depth gauge tip was bent and broke.Eight threaded drill guide, four drill bit, two end cap, two cannulated chisel, two chisel guide, and locking compression plate (lcp) proximal humerus plate had an unknown allegation.There was a surgical delay of five minutes.Procedure outcome is unknown.No patient consequence.This complaint involves twenty-three (23) devices.This report is for (1) depth gauge for 2.7mm & small screws.This report is 2 of 2 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: b5.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.B5.

Event Description

It was reported that on an unknown date, the patient underwent an unknown surgery.During the procedure, two depth gauge tips were bent and broken.Eight threaded drill guide, four drill bit, two end cap, two cannulated chisel, two chisel guide, and locking compression plate (lcp) proximal humerus plate had were involved in threads stripping va locking holes.Chisel and guide were bent during process of insertion.No fragments were generated.There was a surgical delay of five minutes.Procedure outcome is unknown.No patient consequence.This report is 4 of 6 for (b)(4).

Event Description

This report is 2 of 4 for (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).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.B5: update.Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and 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.

• 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: 11916744
• MDR Text Key: 253791505
• Report Number: 2939274-2021-02710
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10886982189950
• UDI-Public: (01)10886982189950
• Combination Product (y/n): N
• PMA/PMN Number: PREAMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 05/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2021
• 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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/30/2021
• Patient Sequence Number: 1
• Treatment: 2.0 THRDD GUIDE F/ 2.7 SCR VA AND LCP; 2.0 THRDD GUIDE F/ 2.7 SCR VA AND LCP; 2.0 THRDD GUIDE F/ 2.7 SCR VA AND LCP; 2.0 THRDD GUIDE F/ 2.7 SCR VA AND LCP; 2.0 THRDD GUIDE F/ 2.7 SCR VA AND LCP; 2.0 THRDD GUIDE F/ 2.7 SCR VA AND LCP; 2.0 THRDD GUIDE F/ 2.7 SCR VA AND LCP