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

Catalog Number UNK - SCREWS: TRAUMA

Device Problems Failure to Align (2522); Device-Device Incompatibility (2919)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Date 10/30/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).This report is for an unknown - screw/ unknown lot number.Without the specific part number, the udi number and 510k number is unknown.Complainant part is not expected to be returned for manufacturer review/ investigation.(b)(4).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.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) 2019, during an unknown procedure, the screws would not go through the nail that resulted to a conversion to a tfna.It is unknown if there was a surgical delay.Procedure outcome is unknown. there was no patient harm.This complaint involves nine (9) devices.This report is 6 of 9 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.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

There was a surgical delay of five (5) minutes.The procedure was completely successfully.

• Brand Name: UNK - SCREWS: TRAUMA
• 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: 9350998
• MDR Text Key: 184903554
• Report Number: 2939274-2019-62315
• 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: 10/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK - SCREWS: TRAUMA
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/25/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention