MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.8MM FIXED ANGLE DRILL GUIDE

Model Number 03.127.001

Device Problems Device-Device Incompatibility (2919); Material Twisted/Bent (2981)

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

Event Date 01/01/2021

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, on an unknown procedure, the (1) depth gauge for small screws, (2) protection sleeve/ 11/8, (2) drill sleeve / 4.2mm, (2) screwdriver shaft sddrive 165mm, (6) 2.8mm fixed angle drill guide, (3) 7.3mm cannulated screw 32mm thread/140mm, (1) scr rack 6.5 ti&ss cann scrs-16/32 thrds, (1) lckng attach washer tray rfn-advanced, (2) 2.4 va 2-clmn vlr drp 7h hd/3h sft/rt-s, (2) 2.4 va 2-clmn vlr drp 7h hd/3h sft/lt-s have an unknown allegation.Fixed angle guides don¿t fit into va locking holes, screws were stripped in process.There was no known hospital or patient involvement.This complaint involves twenty-two (22) devices.This report is for (1) 2.8mm fixed angle drill guide.This report is 7 of 13 for (b)(4).

• Brand Name: 2.8MM FIXED ANGLE DRILL GUIDE
• Type of Device: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12063556
• MDR Text Key: 264517062
• Report Number: 2939274-2021-03206
• Device Sequence Number: 1
• Product Code: FZX
• UDI-Device Identifier: 10886982075017
• UDI-Public: (01)10886982075017
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.127.001
• Device Catalogue Number: 03.127.001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/01/2021
• Initial Date FDA Received: 06/24/2021
• 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