MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI MATRIXNEURO SCREW SELF-DRILLING 5MM; BONE PLATE

Catalog Number 04.503.105.01C

Device Problems Break (1069); Entrapment of Device (1212); Difficult to Advance (2920)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/30/2020

Event Type  Injury  

Manufacturer Narrative

Additional procodes gwo, gxr.Complainant part is not expected to be returned for manufacturer review/ investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.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

Device report from synthes reports an event in (b)(6) as follows: it was reported a craniotomy was performed using an pre-prepared abdominal skull bone piece on (b)(6) 2020.The skull bone was prepared and the 2-hole matrix neuro plates were placed with a bridge with 1.5 mm x 5 mm screws.The dr.Inserted the first screw but it did not reach deep enough in the bone.Two additional screws were inserted with the same seating issue.The surgeon decided to remove the screws but at the time of removal all three screws broke leaving the body of the screw in the bone shell.The heads of the screws were removed.The procedure was completed with placement of a smaller 4mm screw.A surgical delay of more than 20 minutes occurred.Patient is stable.Concomitant device reported: unknown plates: trauma (part # unknown, lot # unknown, quantity 1).This is report 2 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.G3: report source health professional.H4, h6: manufacturing location: monument, manufacturing date: january 24, 2019, part number: 04.503.105.01c, - ti matrixneuro screw self- drilling 5mm, lot number: h812207 (non-sterile), lot quantity: (b)(4).Work order traveler met all inspection acceptance criteria.Inspection sheet, inspect dimensional / final inspection met all inspection acceptance criteria.Packaging label log (pll) lmd was reviewed and determined to be conforming.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture.Component part(s) reviewed: part number: 21015, tialnbri4.00, lot number: h692284, lot quantity: (b)(4).Certified test report supplied by (b)(4) dated july 5, 2018 was reviewed and determined to be conforming.Lot summary report dated july 16, 2018 met all inspection acceptance criteria.Raw material receiving/putaway checklist met all inspection acceptance criteria.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture 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: TI MATRIXNEURO SCREW SELF-DRILLING 5MM
• Type of Device: BONE PLATE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10051886
• MDR Text Key: 190780646
• Report Number: 2939274-2020-02328
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• PMA/PMN Number: K123723
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 04/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.503.105.01C
• Device Lot Number: H812207
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/14/2020
• Patient Sequence Number: 1
• Treatment: TI MATRIXNEURO SCREW SELF-DRILLING 5MM; TI MATRIXNEURO SCREW SELF-DRILLING 5MM; UNK - PLATES; TI MATRIXNEURO SCREW SELF-DRILLING 5MM; TI MATRIXNEURO SCREW SELF-DRILLING 5MM; UNK - PLATES
• Patient Outcome(s): Required Intervention