MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC; WASHER, BOLT, NUT, NON-SPINAL CETALLIC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Discomfort (2330); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown washer/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.Based on the information available, it has been determined that no corrective and/or 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 Description

It was reported that on (b)(6) 2019, the patient underwent hardware removal of an unknown 3.0 mm cannulated screw due to the patient experienced irritation.The procedure was successfully completed with 15 minutes of surgical delay.There was no patient consequence.This complaint involves two (2) devices.This report is for one (1) unk - washers.This report is 2 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.Reported as june 27, 2019, however, the correct date of event is (b)(6) 2019.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

Update: (b)(4) complaint is for post-op, and (b)(4) is for intra-op.

• Type of Device: WASHER, BOLT, NUT, NON-SPINAL CETALLIC
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8818671
• MDR Text Key: 152017653
• Report Number: 2939274-2019-59329
• Device Sequence Number: 1
• Product Code: NDG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/22/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention