MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC; SCREW, FIXATION, BONE

Device Problem Fitting Problem (2183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/12/2018

Event Type  malfunction  

Manufacturer Narrative

Patient weight not provided for reporting.This report is for (2) unknown - screws: locking: trauma /unknown lot.Part and lot numbers are unknown; udi number is unknown.Not implanted or explanted.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device was used for treatment, not diagnosis.

Event Description

It was reported that during an orthopedic procedure on (b)(6) 2018, while the surgeon placed cannulated locking screws into the head of the 3 hole proximal humerus plate, the locking screws did not lock into the plate on 2 separate occasions with 2 separate screws.The surgeon used the screwdriver shaft with torque limiting attachment on a power driver to insert the screws.While doing the final locking by hand, the screws continued to turn in the holes as if they had been stripped out.The plate and screws were removed and replaced with a new plate and locking screws were inserted.The new screws locked into the new plate accordingly.It is unknown if there was a surgical delay.There was no patient consequence reported.Concomitant devices reported: unknown screwdriver shaft (part # unknown, lot # unknown, quantity 1), unknown torque limiting attachment (part # unknown, lot # unknown, quantity 1), unknown power driver (part # unknown, lot # unknown, quantity 1).This report is for two unk - screws: locking.This complaint involves two (2) devices.This report is 2 of 2 for (b)(4).

Manufacturer Narrative

Additional information provided.Complainant part is not expected to be returned for manufacturer review/investigation.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

Two (2) different locking screws did not lock into the same plate.Procedure was successfully completed with a surgical delay of 5-10 minutes.Patient outcome was stable.Concomitant devices: screwdriver shaft (part: 03.240.002, lot: unknown, quantity: 1), torque limiting attachment (part: 511.773, lot: unknown, quantity: 1), power driver (part: unknown, lot: unknown, quantity 1).

• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7932363
• MDR Text Key: 122639433
• Report Number: 2939274-2018-54142
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/03/2018
• Patient Sequence Number: 1
• Patient Age: 69 YR