MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.4MM VA LCP 2-COL DSTL RAD PL 6HH/3HS/LT KIT-STERILE; PLATE, FIXATION, BONE

Model Number 02.111.631KS

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Injury (2348)

Event Date 02/24/2020

Event Type  Injury  

Manufacturer Narrative

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) 2020, during distal radius open reduction internal fixation (orif), the nurse presented the surgeon with an expired sterile boxed implant.The implant was placed inside the patient for positioning but was not fixed with screws.The implant was removed from the sterile field once the past expiration was realized.The devices were removed easily.Medical intervention is done with prophylactic antibiotics administered and antibiotic wash out.The patient had just undergone a bi-polar hip procedure immediately preceding the distal radius orif, in which the expired implant was introduced to the field.The procedure was successfully completed with a sixty (60) minute surgical delay.The patient outcome is unknown.This report is for one (1) 2.4mm va lcp 2-col dstl rad pl 6hh/3hs/lt kit-sterile.This is report 1 of 1 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.H4, h6: manufacturing location: parts kitted and sterilized by: lake region medical / inspection and release by: monument, release to warehouse date: 07-mar-2017, expiration date: 31-jan-2020, part number: 02.111.631ks, 2.4mm va lcp 2-col dstl rad pl 6hh/3hs/lt kit-sterile, lot number: h286892 (sterile), lot quantity: 115.Work order traveler met all inspection acceptance criteria.Inspection sheet, incoming final inspection, met all inspection acceptance criteria.Certificate of compliance received from lake region dated 27-feb-2017 was reviewed and determined to be conforming.Note: there was no certificate of (sterility) processing included in this dhr but the certificate supplied by lake region attests to acceptable sterilization.This lot met all visual and packaging criteria at the time of release with no issues documented during the inspection or release of the product that would contribute to this complaint condition.Product was not returned.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.

• Brand Name: 2.4MM VA LCP 2-COL DSTL RAD PL 6HH/3HS/LT KIT-STERILE
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9865224
• MDR Text Key: 184453112
• Report Number: 2939274-2020-01453
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982261571
• UDI-Public: (01)10886982261571
• Combination Product (y/n): N
• PMA/PMN Number: K083694
• 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: 02/24/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: 02.111.631KS
• Device Catalogue Number: 02.111.631KS
• Device Lot Number: H286892
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/24/2020
• Initial Date FDA Received: 03/23/2020
• Supplement Dates Manufacturer Received: 03/25/2020
• Supplement Dates FDA Received: 04/15/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR