MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC TI MATRIXRIB I-PLATE WIDE 2.8MM THICK/11 HOLES - STERILE; PLATE, FIXATION, BONE

Model Number	04.501.104S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient weight not available for reporting.Complainant part is not expected to be returned for manufacturer review/investigation.Device malfunctioned intra-operatively and was not implanted / explanted.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 or Problem Description
It was reported that the patient underwent a surgical procedure on (b)(6) 2017 as treatment for a fractured rib secondary to being involved in a motor vehicle accident.During the procedure, the surgeon was bending an 11-hole matrixrib plate at the back table and it broke in half.The plate fragments were retrieved.There was no harm reported to the patient.Another plate was bent without incident and implanted in the patient.These events resulted in a 2-minute surgical delay.No harm was reported to the patient.The procedure was successfully completed.The patient outcome was reported stable.Concomitant devices reported: bending pliers (part number unknown, lot number unknown, quantity 1).This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Year of birth is not (b)(6).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
Patient date of birth is not known.Dhr review was completed.Part no.: 04.501.104s, lot no.: l193252, manufacturing location: (b)(4), release to warehouse date: 09.Jan.2017, expiry date: 30.Nov.2026.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Corrected data: date of event, concomitant device therapy date.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 MATRIXRIB I-PLATE WIDE 2.8MM THICK/11 HOLES - STERILE
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE : SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7156983
• Report Number: 2939274-2018-50005
• Device Sequence Number: 18867196
• Product Code: HRS
• UDI-Device Identifier: 10887587073330
• UDI-Public: (01)10887587073330(17)261130(10)L193252
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K161590
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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: 04.501.104S
• Device Catalogue Number: 04.501.104S
• Device Lot Number: L193252
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/04/2017
• Supplement Date Received by Manufacturer: 01/12/2018; 01/12/2018
• Initial Report FDA Received Date: 01/02/2018
• Supplement Report FDA Received Date: 01/12/2018; 01/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR