MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 2.9MM TI MATRIXRIB LCKNG SCREW SELF-TAPPING/12MM; SCREW, FIXATION, BONE

Model Number	04.501.022.01
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Event occurred on an unknown date is (b)(6) 2017.Device remains implanted.Device is not expected to return for 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported one (1) matrix rib screw became dislodged post-operatively on an unknown date in (b)(6).The original surgery occurred (b)(6) 2017 for a pectus exavatum procedure.Two plates and an unknown quantity of screws were originally implanted.The initial post-operative ct scan confirmed proper implant placement.The patient was scanned again (b)(6) 2017 and discovered the screw had backed out of one of the plates (04.501.096).Surgeon decided to leave screw in place as it has scarred in and no chance of migration.No revision is currently planned.Concomitant devices: plate (part# 04.501.096, lot# unknown, qty 1).Plate (part# 04.501.094, lot# unknown, qty 1).Screws (part# unknown, lot# unknown, qty unknown).This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
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.
Additional 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.D8: device is a single use device but was not reprocessed or reused.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 2.9MM TI MATRIXRIB LCKNG SCREW SELF-TAPPING/12MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE : SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7159694
• Report Number: 2939274-2018-50026
• Device Sequence Number: 63670
• Product Code: HWC
• UDI-Device Identifier: 10887587017198
• UDI-Public: (01)10887587017198(10)LOTNUMBERUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K161590
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.501.022.01
• Device Catalogue Number: 04.501.022.01
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/05/2017
• Supplement Date Received by Manufacturer: 01/29/2018; 04/13/2018
• Initial Report FDA Received Date: 01/03/2018
• Supplement Report FDA Received Date: 01/29/2018; 04/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Weight: 77