MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - SCREWDRIVERS

Device Problems Break (1069); Material Twisted/Bent (2981)

Patient Problem No Code Available (3191)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

This report is for an unk - screwdrivers: trauma/unknown lot.Part and lot numbers are unknown; udi number is unknown.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.(b)(4).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 a revision procedure on an unknown date, the unknown cannulated screwdriver broke off in the process of removing the screws.It was mentioned that the first two screws were extracted using a manual driver.On the final screw, the cannulated screw driver broke in the screw head and the metal fragments were excised using c-arm imaging and a kocher.The stripped screw was excised using a combination of an additional driver, pliers, kocher, and other techniques.An x-ray was obtained prior to closure, residual small fragment left behind due to depth and location.The surgeon felt retrieving this fragment would require a larger incision, and potential muscle destruction to obtain visualization and removal and due to its location.It is unknown if there was a surgical delay.Patient status and surgical outcome were unknown.Concomitant device reported: unknown cannulated screws (part # unknown, lot # unknown, quantity # 2).This is report 1 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.This report is against user facility medwatch number (b)(4), a copy is attached.The only information contained in this report is correction or additional information.H6: patient code 3191 used to capture surgical intervention and device failure.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: UNK - SCREWDRIVERS
• Type of Device: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9530044
• MDR Text Key: 181577115
• Report Number: 2939274-2019-62792
• Device Sequence Number: 1
• Product Code: HXX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/03/2019
• Initial Date FDA Received: 12/30/2019
• Supplement Dates Manufacturer Received: 01/29/2020
• Supplement Dates FDA Received: 01/29/2020
• Patient Sequence Number: 1
• Treatment: UNK - SCREWS: CANNULATED
• Patient Outcome(s): Required Intervention