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

Model Number	03.127.001
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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, and (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 1 of 13 for (b)(4).

• Brand Name: 2.8MM FIXED ANGLE DRILL GUIDE
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12063343
• Report Number: 2939274-2021-03198
• Device Sequence Number: 4203097
• Product Code: FZX
• UDI-Device Identifier: 10886982075017
• UDI-Public: (01)10886982075017
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/02/2021

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
• Operator of Device: Health Professional
• Device Model Number: 03.127.001
• Device Catalogue Number: 03.127.001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/02/2021
• Initial Report FDA Received Date: 06/24/2021
• Patient Sequence Number: 1