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

Device Problem Unintended Movement (3026)

Patient Problems Unspecified Infection (1930); Nerve Damage (1979); Impaired Healing (2378); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown screw/unknown lot.Part and lot numbers are unknown; udi number is unknown.Implant date unknown.Complainant part is not expected to be returned for manufacturer review/investigation.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.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 (b)(6) 2018, the patient had a bone graft harvested to fill a bone void in the right humerus.This also included revision surgery due to chronic non-union, radial nerve palsy and infection.The masquolet technique was performed for the bone void.Locking screws were still locked into the locking compression (lcp) extra articular distal humerus plate, but the distal portion of the humerus bone pulled away from the plate.The surgeon reduced the fragment back to the plate and implanted new screws.The plate remained in the patient.Only four (4) screws were replaced in the distal portion of the plate after the surgeon reduced the bone.Patient and surgical outcome are unknown.This is report 1 of 3 for (b)(4).

Event Description

It was reported that on (b)(6) 2018, patient had a harvested bone graft using reamer/ irrigator/ aspirator (ria) technique from the patient¿s right femur due to chronic non-union, radial nerve palsy and infection.The masquolet technique was performed for this bone void.Locking screws were still locked into the locking compression (lcp) extra articular distal humerus plate, but the distal portion of the humerus pulled away from the plate.Some of the distal screws have lost their purchase in the bone of the distal humerus only.The surgeon exchanged distal screws with new ones.The surgeon reduced the fragment back to the plate.The plate was not removed and most of the screws remained in the patient.Only four (4) screws were replaced in the distal portion of the plate after the surgeon reduced the bone.Surgical outcome and patient status are unknown.This report is for four (4) unknown locking screws.This is report 1 of 3 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.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.

• 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: 7894989
• MDR Text Key: 120900351
• Report Number: 2939274-2018-53891
• 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: 08/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/26/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Weight: 98